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1.  Evaluating Drug Prices, Availability, Affordability, and Price Components: Implications for Access to Drugs in Malaysia 
PLoS Medicine  2007;4(3):e82.
Background
Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components.
Methods and Findings
The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%–76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high—25%–38% and 100%–140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector.
Conclusions
The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required.
Drug price and availability data were collected from West Malaysian public sector facilities, private sector retail pharmacies, and dispensing doctors. Mark-ups were higher on generic drugs than on innovator brands.
Editors' Summary
Background.
The World Health Organization has said that one-third of the people of the world cannot access the medicines they need. An important reason for this problem is that prices are often too high for people or government-funded health systems to afford. In developing countries, most people who need medicines have to pay for them out of their own pockets. Where the cost of drugs is covered by health systems, spending on medicines is a major part of the total healthcare budget. Governments use a variety of approaches to try to control the cost of drugs and make sure that essential medicines are affordable and not overpriced. According to the theory of “free market economics,” the costs of goods and services are determined by interactions between buyers and sellers and not by government intervention. However, free market economics does not work well at containing the costs of medicines, particularly new medicines, because new medicines are protected by patent law, which legally prevents others from making, using, or selling the medicine for a particular period of time. Therefore, without government intervention, there is nothing to help to push down prices.
Why Was This Study Done?
Malaysia is a middle-income country with a relatively effective public health system, but it is facing a rapid rise in drug costs. In Malaysia, medicine prices are determined by free-market economics, without any control by government. Government hospitals are expected to provide drugs free, but a substantial proportion of medicines are paid for by patients who buy them directly from private pharmacies or prescribing doctors. There is evidence that Malaysian patients have difficulties accessing the drugs they need and that cost is an important factor. Therefore, the researchers who wrote this paper wanted to examine the cost of different medicines in Malaysia, and their availability and affordability from different sources.
What Did the Researchers Do and Find?
In this research project, 48 drugs were studied, of which 28 were part of a “core list” identified by the World Health Organization as “essential drugs” on the basis of the global burden of disease. The remaining 20 reflected health care needs in Malaysia itself. The costs of each medicine were collected from government hospitals, private pharmacies, and dispensing doctors in four different regions of Malaysia. Data were collected for the “innovator brand” (made by the original patent holder) and for “generic” brands (an equivalent drug to the innovator brand, produced by a different company once the innovator brand no longer has an exclusive patent). The medicine prices were compared against international reference prices (IRP), which are the average prices offered by not-for-profit drug companies to developing countries. Finally, the researchers also compared the cost of the drugs with daily wages, in order to work out their “affordability.”
The researchers found that, irrespective of the source of medicines, prices were on average very much higher than the international reference price, ranging from 2.4 times the IRP for innovator brands accessed through public hospitals, to 16 times the IRP for innovator brands accessed through private pharmacies. The availability of medicines was also very poor, with only 25% of generic medicines available on average through the public sector. The affordability of many of the medicines studied was again very poor. For example, one month's supply of ranitidine (a drug for stomach ulcers) was equivalent to around three days' wages for a low-paid government worker, and one month's supply of fluoxetine (an antidepressant) would cost around 26 days' wages.
What Do These Findings Mean?
These results show that essential drugs are very expensive in Malaysia and are not universally available. Many people would not be able to pay for essential medicines. The cost of medicines in Malaysia seems to be much higher than in areas of India and Sri Lanka, although the researchers did not attempt to collect data in order to carry out an international comparison. It is possible that the high cost and low availability in Malaysia are the result of a lack of government regulation. Overall, the findings suggest that the government should set up mechanisms to prevent drug manufacturers from increasing prices too much and thus ensure greater access to essential medicines.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040082.
Read a related PLoS Medicine Perspective article by Suzanne Hill
Information is available from the World Health Organization on Improving Access to Medicines
Information on medicine prices is available from Health Action International
Wikipedia has an entry on Patent (a type of intellectual property that is normally used to prevent other companies from selling a newly invented medicine). (Wikipedia is an internet encyclopedia anyone can edit.)
The Drugs for Neglected Diseases Initiative is an international collaboration between public organizations that aims to develop drugs for people suffering from neglected diseases
doi:10.1371/journal.pmed.0040082
PMCID: PMC1831730  PMID: 17388660
2.  Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment  
PLoS Medicine  2007;4(11):e305.
Background
Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART) for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs), procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005.
Methods and Findings
We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir–ritonavir (lopinavir/r) have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs: patented lopinavir/r, efavirenz, tenofovir, atazanavir, enfuvirtide, and a locally produced generic, fixed-dose combination of zidovudine and lamivudine (AZT/3TC). Because prices declined for many of the patented drugs that constitute the largest share of drug costs, nearly the entire increase in overall drug expenditures between 2001 and 2005 is attributable to increases in drug quantities. Had all drug quantities been held constant from 2001 until 2005 (or for those drugs entering treatment guidelines after 2001, held constant between the year of introduction and 2005), total costs would have increased by only an estimated US$7 million. We estimate that in the absence of price declines for patented drugs, Brazil would have spent a cumulative total of US$2 billion on drugs for HAART between 2001 and 2005, implying a savings of US$1.2 billion from price declines. Finally, in comparing Brazilian prices for locally produced generic ARVs to the lowest international prices meeting global pharmaceutical quality standards, we find that current prices for Brazil's locally produced generics are generally much higher than corresponding global prices, and note that these prices have risen in Brazil while declining globally. We estimate the excess costs of Brazil's locally produced generics totaled US$110 million from 2001 to 2005.
Conclusions
Despite Brazil's more costly generic ARVs, the net result of ARV price changes has been a cost savings of approximately US$1 billion since 2001. HAART costs have nevertheless risen steeply as Brazil has scaled up treatment. These trends may foreshadow future AIDS treatment cost trends in other developing countries as more people start treatment, AIDS patients live longer and move from first-line to second and third-line treatment, AIDS treatment becomes more complex, generic competition emerges, and newer patented drugs become available. The specific application of the Brazilian model to other countries will depend, however, on the strength of their health systems, intellectual property regulations, epidemiological profiles, AIDS treatment guidelines, and differing capacities to produce drugs locally.
Amy Nunn and colleagues analyze the cost of antiretroviral drugs in Brazil between 2001 and 2005 and discuss the implications for HIV treatment in other developing countries.
Editors' Summary
Background.
Acquired immunodeficiency syndrome (AIDS) has killed 29 million people since the first case occurred in 1981 and an estimated 40 million people live with HIV/AIDS today. AIDS is caused by the human immunodeficiency virus (HIV), which destroys the immune system. Infected individuals are consequently very susceptible to other infections. Early in the AIDS epidemic, most HIV-positive individuals died within a few years of becoming infected. Then, in 1996, highly active antiretroviral therapy (HAART)—a cocktail of antiretroviral drugs (ARVs)—was developed. For people who could afford HAART (which holds HIV infections in check), AIDS became a chronic disease. People who start HAART must keep taking it or their illness will progress.
Unfortunately, few people in low- and middle-income countries could afford these expensive drugs. In 2001, ARV prices fell in developing countries as AIDS activists and developing country governments challenged pharmaceutical companies about ARV prices, pharmaceutical companies set tiered prices for the low- and middle-income countries and more generic (inexpensive copies of brand-named drugs) ARVs became available. In 2003, the lack of access to HIV/AIDS treatment was declared a global health emergency. Governments, international organizations, and funding bodies began to set targets and provide funds to increase access to HAART in developing countries. By 2007, over 2 million people in low- and middle-income countries had access to HAART, but another 5 million remain in urgent need of drugs for treatment.
Why Was This Study Done?
In 1995, many countries in the world signed the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, which requires countries to acknowledge intellectual property rights for many products, including pharmaceuticals. In 1996, Brazil became the first developing country to commit to and implement policies to provide free and universal access to HAART. Since then, Brazil's successful AIDS treatment program has become a model for the developing world, and 180,000 Brazilians were receiving HAART at the end of 2006. However, as a WTO member that signed on to the TRIPS agreement, Brazil was required to recognize the intellectual property rights of pharmaceutical companies' patented ARVs. As Brazil scaled up treatment in the late 1990s, the cost of treating AIDS patients rose quickly and the country took controversial public policy steps to reduce the cost of providing HAART to people living with HIV/AIDS. Brazil produces several non-patented ARVs locally, and since 2001 has challenged multinational pharmaceutical companies about the prices of patented ARVs. To induce price reductions for patented ARVs, Brazil has threatened to issue compulsory licenses (which under WTO terms allow countries facing a health emergency to produce patented drugs without consent of the company holding the patent). Brazil also recently issued a compulsory license for one ARV.
Although world leaders have set a target of universal access to HAART by 2010, little is known about the long-term costs of AIDS treatment in developing countries. In this study, the researchers have investigated how and why the costs of ARVs changed in Brazil between 2001 and 2005 and discuss the relevance of the Brazilian model for AIDS treatment for other resource-limited settings.
What Did the Researchers Do and Find?
The researchers analyzed the prices for each ARV recommended in Brazil's therapeutic guidelines for adults and estimated the changes in purchase quantities for each between 2001 and 2005. These changes likely stem from the growing number of options in Brazil's treatment guidelines, the steadily rising number of patients commencing treatment, and patients' shifts to second- and third-line treatments when their HIV infection became resistant to first-line drugs or they developed side effects. The researchers report that the generic drugs produced in Brazil were generally more expensive than similar drugs made elsewhere, but Brazil's negotiated drug prices for many patented ARVs were lower than elsewhere. Overall, total annual drug expenditure on ARVs doubled between 2001 and 2005, reaching US$414 million in 2005. Because many drug prices fell sharply as a result of declining patented drug prices over the study period, this increase was mainly attributable to increases in drug quantities purchased. If these quantities had stayed constant, the total annual cost would have increased by only $7 million, to $211 million. Conversely, without the decrease in the price of patented drugs, Brazil would have spent $952 million annually by 2005. If Brazil had enjoyed the lowest global prices for generic medicines, the total costs per year in 2005 would have been $367 million, or nearly $50 million less than the costs Brazil actually realized.
What Do These Findings Mean?
These findings tease out the many factors—clinical, commercial, and political—that affected the total costs of the Brazilian AIDS treatment program between 2001 and 2005.
Brazil's ability to produce generic drugs facilitated Brazil's price negotiations for patented drugs. Although Brazil saved approximately US$1 billion over the study period as a result of declining prices for patented medicines, the cost of producing generic drugs locally has risen while the prices for generic drugs have fallen elsewhere. Brazil's recent decision to import a generic ARV using a compulsory license suggests that the Brazilian model for AIDS treatment continues to evolve.
Questions remain about the precise causes of year-to-year cost trends in Brazil because, for example, the researchers did not have full data on when patients switched from first-line to second- or third-line drugs. The observed steep rise in costs from 2004 to 2005 in particular warrants further analysis. In addition, the findings may not be generalizable to countries with different policies on HIV/AIDS treatment, different access to generic drugs, or different bargaining power with multinational drug companies. Nevertheless, the trends this study highlights provide important information about how AIDS treatment costs are likely to evolve in other developing countries as efforts are made to provide universal access to life-saving ARVs.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040305.
Information from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS
Information from the US Centers for Disease Control and Prevention on global HIV/AIDS topics (in English and Spanish)
HIV InSite, comprehensive and up-to-date information on all aspects of HIV/AIDS from the University of California San Francisco
Information from Avert, an international AIDS charity, on HIV and AIDS in Brazil and on HIV/AIDS treatment and care, including universal access to ARVs
Progress towards universal access to HIV/AIDS treatment, the latest report from the World Health Organization (available in several languages)
The National STD and AIDS Program of Brazil
doi:10.1371/journal.pmed.0040305
PMCID: PMC2071936  PMID: 18001145
3.  Trends in Compulsory Licensing of Pharmaceuticals Since the Doha Declaration: A Database Analysis 
PLoS Medicine  2012;9(1):e1001154.
Reed Beall and Randall Kuhn describe their findings from an analysis of use of compulsory licenses for pharmaceutical products by World Trade Organization members since 1995.
Background
It is now a decade since the World Trade Organization (WTO) adopted the “Declaration on the TRIPS Agreement and Public Health” at its 4th Ministerial Conference in Doha. Many anticipated that these actions would lead nations to claim compulsory licenses (CLs) for pharmaceutical products with greater regularity. A CL is the use of a patented innovation that has been licensed by a state without the permission of the patent title holder. Skeptics doubted that many CLs would occur, given political pressure against CL activity and continued health system weakness in poor countries. The subsequent decade has seen little systematic assessment of the Doha Declaration's impact.
Methods and Findings
We assembled a database of all episodes in which a CL was publically entertained or announced by a WTO member state since 1995. Broad searches of CL activity were conducted using media, academic, and legal databases, yielding 34 potential CL episodes in 26 countries. Country- and product-specific searches were used to verify government participation, resulting in a final database of 24 verified CLs in 17 nations. We coded CL episodes in terms of outcome, national income, and disease group over three distinct periods of CL activity. Most CL episodes occurred between 2003 and 2005, involved drugs for HIV/AIDS, and occurred in upper-middle-income countries (UMICs). Aside from HIV/AIDS, few CL episodes involved communicable disease, and none occurred in least-developed or low-income countries.
Conclusions
Given skepticism about the Doha Declaration's likely impact, we note the relatively high occurrence of CLs, yet CL activity has diminished markedly since 2006. While UMICs have high CL activity and strong incentives to use CLs compared to other countries, we note considerable countervailing pressures against CL use even in UMICs. We conclude that there is a low probability of continued CL activity. We highlight the need for further systematic evaluation of global health governance actions.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The development of a new drug is a time-consuming and expensive process. To stimulate investment in drug development, the creators of new drugs (including the pharmaceutical companies that undertake the development and testing that is needed before any drug can be used in patients) can apply for “intellectual property rights” (a patent). Intellectual property rights protect the investments made by companies during drug development by preventing other companies from making the new drug for a fixed period of time and by providing a means by which creators of new drugs can negotiate payment from other companies for the use of their creation. Until recently, the extent and enforcement of intellectual property rights varied widely around the world. Then, in 1995, the World Trade Organization (WTO) was established. By providing a set of ground rules for trade among nations, the WTO aims to ensure that trade flows as smoothly, predictably, and freely as possible around the world. One of the founding documents of the WTO is the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which attempts to bring the protection of intellectual property rights (including patents) under common international rules.
Why Was This Study Done?
Unfortunately, patent protection for drugs (pharmaceuticals) means that many medicines are too expensive for use in developing countries. While maintaining incentives for drug development, the TRIPS Agreement allows governments to license the use of patented inventions to someone else without the consent of the patent owner. Such “compulsory licensing” normally occurs only after negotiations for a voluntary license have failed, and the patent owner still receives an appropriate payment. It soon became clear that some governments were unsure of their right to use compulsory licensing and other flexibilities in the TRIPS Agreement, a situation likely to affect public health in poor countries by hindering universal access to medicines. Consequently, the WTO issued the “Declaration on the TRIPS Agreement and Public Health” at its 4th Ministerial Conference in Doha in November 2001. Reaction to the Doha Declaration, which reaffirms that the “TRIPS Agreement does not and should not prevent members from taking measures to protect public health,” has been mixed. Some experts predicted that it would increase compulsory licensing of pharmaceuticals, but others suggested that political pressure against compulsory licensing and health system weaknesses in poor countries would limit claims for compulsory licenses. In this database analysis, the researchers systematically assess the impact of the Doha Declaration on the compulsory licensing of pharmaceuticals.
What Did the Researchers Do and Find?
By systematically searching media archives for reports of WTO member states considering or announcing compulsory licensing of pharmaceuticals, the researchers identified 24 verified compulsory licensing episodes in 17 nations that occurred between January 1995 and June 2011. Half of these episodes ended with an announcement of a compulsory license, and the majority ended in a price reduction for a specific pharmaceutical product for the potential issuing nation through a compulsory license, a voluntary license, or a negotiated discount. Sixteen of the compulsory licensing episodes involved drugs for HIV/AIDS, four involved drugs for other communicable diseases, and four involved drugs for non-communicable diseases such as cancer. More than half the compulsory licensing episodes occurred in upper-middle-income countries (including Brazil and Thailand). Finally, most compulsory licensing episodes occurred between 2003 and 2005. There was a smaller peak of activity in the months leading up to the Doha conference, but after 2006 activity declined substantially.
What Do These Findings Mean?
Given these findings, the researchers suggest that the Doha Declaration is unlikely to have an important long-term impact on the use of compulsory licensing or on access to pharmaceuticals for communicable diseases other than HIV/AIDS in developing and low-income countries. Most notably, the researchers found no evidence of a spike in compulsory licensing episodes immediately after the Doha Declaration, and they note that the lagged spike that occurred between 2003 and 2005 could have resulted in large part from the global antiretroviral advocacy campaign. Moreover, compulsory licensing activity has diminished greatly since 2006. Thus, the researchers conclude, health advocates who pushed for the Doha Declaration reforms have had little success in engaging trade as a positive, proactive force for addressing health gaps.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001154.
The World Trade Organization provides information on intellectual property rights, on the TRIPS Agreement, on TRIPS and pharmaceutical patents, and on compulsory licensing of pharmaceuticals and TRIPS (in English, French, and Spanish); the Doha Declaration on the TRIPS Agreement and Public Health is also available
The World Health Organization provides information on the Doha Declaration on the TRIPS Agreement and Public Health and an analysis of the implications of the Doha Declaration
Wikipedia has pages on intellectual property rights, on the TRIPS Agreement, and on the Doha Declaration (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
doi:10.1371/journal.pmed.1001154
PMCID: PMC3254665  PMID: 22253577
4.  Reinterpreting Ethnic Patterns among White and African American Men Who Inject Heroin: A Social Science of Medicine Approach 
PLoS Medicine  2006;3(10):e452.
Background
Street-based heroin injectors represent an especially vulnerable population group subject to negative health outcomes and social stigma. Effective clinical treatment and public health intervention for this population requires an understanding of their cultural environment and experiences. Social science theory and methods offer tools to understand the reasons for economic and ethnic disparities that cause individual suffering and stress at the institutional level.
Methods and Findings
We used a cross-methodological approach that incorporated quantitative, clinical, and ethnographic data collected by two contemporaneous long-term San Francisco studies, one epidemiological and one ethnographic, to explore the impact of ethnicity on street-based heroin-injecting men 45 years of age or older who were self-identified as either African American or white. We triangulated our ethnographic findings by statistically examining 14 relevant epidemiological variables stratified by median age and ethnicity. We observed significant differences in social practices between self-identified African Americans and whites in our ethnographic social network sample with respect to patterns of (1) drug consumption; (2) income generation; (3) social and institutional relationships; and (4) personal health and hygiene. African Americans and whites tended to experience different structural relationships to their shared condition of addiction and poverty. Specifically, this generation of San Francisco injectors grew up as the children of poor rural to urban immigrants in an era (the late 1960s through 1970s) when industrial jobs disappeared and heroin became fashionable. This was also when violent segregated inner city youth gangs proliferated and the federal government initiated its “War on Drugs.” African Americans had earlier and more negative contact with law enforcement but maintained long-term ties with their extended families. Most of the whites were expelled from their families when they began engaging in drug-related crime. These historical-structural conditions generated distinct presentations of self. Whites styled themselves as outcasts, defeated by addiction. They professed to be injecting heroin to stave off “dopesickness” rather than to seek pleasure. African Americans, in contrast, cast their physical addiction as an oppositional pursuit of autonomy and pleasure. They considered themselves to be professional outlaws and rejected any appearance of abjection. Many, but not all, of these ethnographic findings were corroborated by our epidemiological data, highlighting the variability of behaviors within ethnic categories.
Conclusions
Bringing quantitative and qualitative methodologies and perspectives into a collaborative dialog among cross-disciplinary researchers highlights the fact that clinical practice must go beyond simple racial or cultural categories. A clinical social science approach provides insights into how sociocultural processes are mediated by historically rooted and institutionally enforced power relations. Recognizing the logical underpinnings of ethnically specific behavioral patterns of street-based injectors is the foundation for cultural competence and for successful clinical relationships. It reduces the risk of suboptimal medical care for an exceptionally vulnerable and challenging patient population. Social science approaches can also help explain larger-scale patterns of health disparities; inform new approaches to structural and institutional-level public health initiatives; and enable clinicians to take more leadership in changing public policies that have negative health consequences.
Bourgois and colleagues found that the African American and white men in their study had a different pattern of drug use and risk behaviors, adopted different strategies for survival, and had different personal histories.
Editors' Summary
Background.
There are stark differences in the health of different ethnic groups in America. For example, the life expectancy for white men is 75.4 years, but it is only 69.2 years for African-American men. The reasons behind these disparities are unclear, though there are several possible explanations. Perhaps, for example, different ethnic groups are treated differently by health professionals (with some groups receiving poorer quality health care). Or maybe the health disparities are due to differences across ethnic groups in income level (we know that richer people are healthier). These disparities are likely to persist unless we gain a better understanding of how they arise.
Why Was This Study Done?
The researchers wanted to study the health of a very vulnerable community of people: heroin users living on the streets in the San Francisco Bay Area. The health status of this community is extremely poor, and its members are highly stigmatized—including by health professionals themselves. The researchers wanted to know whether African American men and white men who live on the streets have a different pattern of drug use, whether they adopt varying strategies for survival, and whether they have different personal histories. Knowledge of such differences would help the health community to provide more tailored and culturally appropriate interventions. Physicians, nurses, and social workers often treat street-based drug users, especially in emergency rooms and free clinics. These health professionals regularly report that their interactions with street-based drug users are frustrating and confrontational. The researchers hoped that their study would help these professionals to have a better understanding of the cultural backgrounds and motivations of their drug-using patients.
What Did the Researchers Do and Find?
Over the course of six years, the researchers directly observed about 70 men living on the streets who injected heroin as they went about their usual lives (this type of research is called “participant observation”). The researchers specifically looked to see whether there were differences between the white and African American men. All the men gave their consent to be studied in this way and to be photographed. The researchers also studied a database of interviews with almost 7,000 injection drug users conducted over five years, drawing out the data on differences between white and African men. The researchers found that the white men were more likely to supplement their heroin use with inexpensive fortified wine, while African American men were more likely to supplement heroin with crack. Most of the white men were expelled from their families when they began engaging in drug-related crime, and these men tended to consider themselves as destitute outcasts. African American men had earlier and more negative contact with law enforcement but maintained long-term ties with their extended families, and these men tended to consider themselves as professional outlaws. The white men persevered less in attempting to find a vein in which to inject heroin, and so were more likely to inject the drug directly under the skin—this meant that they were more likely to suffer from skin abscesses. The white men generated most of their income from panhandling (begging for money), while the African American men generated most of their income through petty crime and/or through offering services such as washing car windows at gas stations.
What Do These Findings Mean?
Among street-based heroin users, there are important differences between white men and African American men in the type of drugs used, the method of drug use, their social backgrounds, the way in which they identify themselves, and the health risks that they take. By understanding these differences, health professionals should be better placed to provide tailored and appropriate care when these men present to clinics and emergency rooms. As the researchers say, “understanding of different ethnic populations of drug injectors may reduce difficult clinical interactions and resultant physician frustration while improving patient access and adherence to care.” One limitation of this study is that the researchers studied one specific community in one particular area of the US—so we should not assume that their findings would apply to street-based heroin users elsewhere.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030452.
The US Centers for Disease Control (CDC) has a web page on HIV prevention among injection drug users
The World Health Organization has collected documents on reducing the risk of HIV in injection drug users and on harm reduction approaches
The International Harm Reduction Association has information relevant to a global audience on reducing drug-related harm among individuals and communities
US-focused information on harm reduction is available via the websites of the Harm Reduction Coalition and the Chicago Recovery Alliance
Canada-focused information can be found at the Street Works Web site
The Harm Reduction Journal publishes open-access articles
The CDC has a web page on eliminating racial and ethnic health disparities
The Drug Policy Alliance has a web page on drug policy in the United States
doi:10.1371/journal.pmed.0030452
PMCID: PMC1621100  PMID: 17076569
5.  Experiences with Policing among People Who Inject Drugs in Bangkok, Thailand: A Qualitative Study 
PLoS Medicine  2013;10(12):e1001570.
Using thematic analysis, Kerr and colleagues document the experiences of policing among people who inject drugs in Bangkok and examine how interactions with police can affect drug-using behaviors and health care access.
Please see later in the article for the Editors' Summary
Background
Despite Thailand's commitment to treating people who use drugs as “patients” not “criminals,” Thai authorities continue to emphasize criminal law enforcement for drug control. In 2003, Thailand's drug war received international criticism due to extensive human rights violations. However, few studies have since investigated the impact of policing on drug-using populations. Therefore, we sought to examine experiences with policing among people who inject drugs (PWID) in Bangkok, Thailand, between 2008 and 2012.
Methods and Findings
Between July 2011 and June 2012, semi-structured, in-depth interviews were conducted with 42 community-recruited PWID participating in the Mitsampan Community Research Project in Bangkok. Interviews explored PWID's encounters with police during the past three years. Audio-recorded interviews were transcribed verbatim, and a thematic analysis was conducted to document the character of PWID's experiences with police. Respondents indicated that policing activities had noticeably intensified since rapid urine toxicology screening became available to police. Respondents reported various forms of police misconduct, including false accusations, coercion of confessions, excessive use of force, and extortion of money. However, respondents were reluctant to report misconduct to the authorities in the face of social and structural barriers to seeking justice. Respondents' strategies to avoid police impeded access to health care and facilitated transitions towards the misuse of prescribed pharmaceuticals. The study's limitations relate to the transferability of the findings, including the potential biases associated with the small convenience sample.
Conclusions
This study suggests that policing in Bangkok has involved injustices, human rights abuses, and corruption, and policing practices in this setting appeared to have increased PWID's vulnerability to poor health through various pathways. Novel to this study are findings pertaining to the use of urine drug testing by police, which highlight the potential for widespread abuse of this emerging technology. These findings raise concern about ongoing policing practices in this setting.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In many countries, the dominant strategy used to control illegal drugs such as heroin and methamphetamine is criminal law enforcement, a strategy that sometimes results in human rights abuses such as ill-treatment by police, extrajudicial killings, and arbitrary detention. Moreover, growing evidence suggests that aggressive policing of illicit drug use can have adverse public-health consequences. For example, the fear engendered by intensive policing may cause people who inject drugs (PWID) to avoid services such as needle exchanges, thereby contributing to the HIV/AIDS epidemic. One country with major epidemics of illicit drug use and of HIV/AIDS among PWID is Thailand. Although Thailand reclassified drug users as “patients” instead of “criminals” in 2002, possession and consumption of illicit drugs remain criminal offenses. The 2002 legislation also created a system of compulsory drug detention centers, most of which lack evidence-based addiction treatment services. In 2003, the Thai government launched a campaign to suppress drug trafficking and to enrol 300,000 people who use drugs into treatment. This campaign received international criticism because it involved extensive human rights violations, including more than 2,800 extrajudicial killings of suspected drug users and dealers.
Why Was This Study Done?
Drug-related arrests and compulsory detention of drug users are increasing in Thailand but what is the impact of current policing practices on drug users and on public health? In this qualitative study (a study that aims for an in-depth understanding of human behavior), the researchers use thematic analysis informed by the Rhodes' Risk Environment Framework to document the social and structural factors that led to encounters with the police among PWID in Bangkok between 2008 and 2012, the policing tactics employed during these encounters, and the associated health consequences of these encounters. The Risk Environment Framework posits that a range of social, political, economic, and physical environmental factors interact with each other and shape the production of drug-related harm.
What Did the Researchers Do and Find?
Between July 2011 and June 2012, the researchers conducted in-depth interviews with a convenience sample (a non-random sample from a nearby population) of 42 participants in the Mitsampan Community Research Project, an investigation of drug-using behavior, health care access, and drug-related harms among PWID in Bangkok. Respondents reported that policing activities had intensified since rapid urine toxicology screening became widely available and since the initiation of a crackdown on drug users in 2011. They described various forms of violence and misconduct that they had experienced during confrontations with police, including false accusations, degrading stop and search procedures, and excessive use of force. Urine drug testing was identified as a key tool used by the police, with some respondents describing how police caused unnecessary humiliation by requesting urine samples in public places. It was also reported that the police used positive test results as a means of extortion. Finally, some respondents reported feeling powerless in relation to the police and cited fear of retaliation as an important barrier to obtaining redress for police corruption. Others reported that they had adopted strategies to avoid the police such as staying indoors, a strategy likely to impede access to health care, or changing their drug-using behavior by, for example, injecting midazolam rather than methamphetamine, a practice associated with an increased risk of injection-related complications.
What Do These Findings Mean?
These findings suggest that the policing of PWID in Bangkok between 2008 and 2012 involved injustices, human rights abuses, and corruption and highlight the potential for widespread misuse of urine drug testing. Moreover, they suggest that policing practices in this setting may have increased the vulnerability of PWID to poor health by impeding their access to health care and by increasing the occurrence of risky drug-using behaviors. Because this study involved a small convenience sample of PWID, these findings may not be generalizable to other areas of Bangkok or Thailand and do not indicate whether police misconduct and corruption is highly prevalent across the all police departments in Bangkok. Nevertheless, these findings suggest that multilevel structural changes and interventions are needed to mitigate the harm associated with policing of illicit drug use in Bangkok. These changes will need to ensure full accountability for police misconduct and access to legal services for victims of this misconduct. They will also need to include ethical guidelines for urine drug testing and the reform of policies that promote repressive policing and compulsory detention.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001570.
This study is further discussed in a PLOS Medicine Perspective by Burris and Koester
Human Rights Watch, a global organization dedicated to defending and protecting human rights, has information about drug policy and human rights, which includes information on Thailand
The Global Commission on Drug Policy published a report in June 2012 entitled “The War on Drugs and HIV/AIDS: How the Criminalization of Drug Use Fuels the Global Pandemic” (available in several languages)
The Global Commission on HIV and the Law published a report in July 2012 entitled “HIV and the Law: Risk, Rights and Health” (available in several languages), the Open Society Foundations have prepared a briefing on this report
More information about the Mitsampan Community Research Project is available
doi:10.1371/journal.pmed.1001570
PMCID: PMC3858231  PMID: 24339753
6.  Representation and Misrepresentation of Scientific Evidence in Contemporary Tobacco Regulation: A Review of Tobacco Industry Submissions to the UK Government Consultation on Standardised Packaging 
PLoS Medicine  2014;11(3):e1001629.
Selda Ulucanlar and colleagues analyze submissions by two tobacco companies to the UK government consultation on standardized packaging.
Please see later in the article for the Editors' Summary
Background
Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for ‘more evidence’, but four months later a second ‘independent review’ was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP.
Methods and Findings
We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, ‘mimicked scientific critique’ was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in ‘evidential landscaping’, promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach.
Conclusions
The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 6 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to more than 8 million by 2030. To reduce this loss of life, national and international bodies have drawn up various conventions and directives designed to implement tobacco control measures such as the adoption of taxation policies aimed at reducing tobacco consumption and bans on tobacco advertising, promotion, and sponsorship. One innovative but largely unused tobacco control measure is standardised packaging of tobacco products. Standardised packaging aims to prevent the use of packaging as a marketing tool by removing all brand imagery and text (other than name) and by introducing packs of a standard shape and colour that include prominent pictorial health warnings. Standardised packaging was first suggested as a tobacco control measure in 1986 but has been consistently opposed by the tobacco industry.
Why Was This Study Done?
The UK is currently considering standardised packaging of tobacco products. In the UK, Better Regulation guidance obliges officials to seek the views of stakeholders, including corporations, on the government's cost and benefit estimates of regulatory measures such as standardised packaging and on the evidence underlying these estimates. In response to a public consultation about standardised packaging in July 2013, which considered submissions from several transnational tobacco companies (TTCs), the UK government announced that it would wait for the results of the standardised packaging legislation that Australia adopted in December 2012 before making its final decision about this tobacco control measure. Parliamentary debates and media statements have suggested that doubt over the adequacy of the evidence was the main reason for this ‘wait and see’ decision. Notably, TTCs have a history of manufacturing uncertainty about the scientific evidence related to the harms of tobacco. Given the centrality of evidence to the debate about standardised packaging, in this study, the researchers analyse submissions made by two TTCs, British American Tobacco (BAT) and Japan Tobacco International (JTI), to the first UK consultation on standardised packaging (a second review is currently underway and will report shortly) to examine how TTCs used evidence to oppose standardised packaging.
What Did the Researchers Do and Find?
The researchers analysed sub-sections of two of the four TTC submissions (those submitted by BAT and JTI) made to the public consultation using verification-oriented cross-documentary analysis, which compared references made to published sources with the original sources to ascertain how these sources had been used, and interpretative analysis to examine the conceptual significance of TTC critiques of the evidence on standardised packaging. The researchers report that the companies' overall argument was that the evidence base in support of standardised packaging was seriously flawed and did not warrant the introduction of such packaging. The researchers identified three ways in which the TTC reports misrepresented the evidence base. First, the TTCs misquoted published studies, thereby distorting the main messages of these studies. For example, the TTCs sometimes omitted important qualifying information when quoting from published studies. Second, the TTCs undermined evidence by employing experts to review published studies for methodological rigor and value in ways that did not conform to normal scientific critique approaches (‘mimicked scientific critique’). So, for example, the experts considered each piece of evidence in isolation for its ability to support standardised packaging rather than considering the cumulative weight of the evidence. Finally, the TTCs engaged in ‘evidential landscaping’. That is, they promoted research that deflected attention from standardised packaging (for example, research into social explanations of smoking behaviour) and omitted internal industry research on the role of packaging in marketing.
What Do These Findings Mean?
These findings suggest that the TTC critique of the evidence in favour of standardised packaging that was presented to the UK public consultation on this tobacco control measure is highly misleading. However, because the researchers' analysis only considered subsections of the submissions from two TTCs, these findings may not be applicable to the other submissions or to other TTCs. Moreover, their analysis only considered the efforts made by TTCs to influence public health policy and not the effectiveness of these efforts. Nevertheless, these findings suggest that the claim of TTCs that standardised packaging will not lead to public health benefits is largely without foundation. More generally, these findings highlight the possibility that the tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for wealthy corporations to slow, weaken, or prevent the implementation of public health policies.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001629.
The World Health Organization provides information about the dangers of tobacco (in several languages) and an article about first experiences with Australia's tobacco plain packaging law; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report ‘Tobacco industry interference with tobacco control’
A UK parliamentary briefing on standardised packaging of tobacco products, a press release about the consultation, and a summary report of the consultation are available; the ideas behind the UK's Better Regulation guidance are described in a leaflet produced by the Better Regulation Task Force
Cancer Research UK (CRUK) has a web page with information on standardised packaging and includes videos
Wikipedia has a page on standardised packaging of tobacco products (note: Wikipedia is a free online encyclopaedia that anyone can edit; available in several languages)
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and the tactics it uses to influence tobacco regulation
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001629
PMCID: PMC3965396  PMID: 24667150
7.  Quality of Private and Public Ambulatory Health Care in Low and Middle Income Countries: Systematic Review of Comparative Studies 
PLoS Medicine  2011;8(4):e1000433.
Paul Garner and colleagues conducted a systematic review of 80 studies to compare the quality of private versus public ambulatory health care in low- and middle-income countries.
Background
In developing countries, the private sector provides a substantial proportion of primary health care to low income groups for communicable and non-communicable diseases. These providers are therefore central to improving health outcomes. We need to know how their services compare to those of the public sector to inform policy options.
Methods and Findings
We summarised reliable research comparing the quality of formal private versus public ambulatory health care in low and middle income countries. We selected studies against inclusion criteria following a comprehensive search, yielding 80 studies. We compared quality under standard categories, converted values to a linear 100% scale, calculated differences between providers within studies, and summarised median values of the differences across studies. As the results for for-profit and not-for-profit providers were similar, we combined them. Overall, median values indicated that many services, irrespective of whether public or private, scored low on infrastructure, clinical competence, and practice. Overall, the private sector performed better in relation to drug supply, responsiveness, and effort. No difference between provider groups was detected for patient satisfaction or competence. Synthesis of qualitative components indicates the private sector is more client centred.
Conclusions
Although data are limited, quality in both provider groups seems poor, with the private sector performing better in drug availability and aspects of delivery of care, including responsiveness and effort, and possibly being more client orientated. Strategies seeking to influence quality in both groups are needed to improve care delivery and outcomes for the poor, including managing the increasing burden of non-communicable diseases.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The provision of private (“for-profit” hospitals and self-employed practitioners, and “not-for-profit” non-government providers, including faith-based organizations) versus public health care services in low and middle income countries raises considerable ideological debate. Ideological arguments aside—which can be very passionate on both sides—there is general agreement that improving the quality of both public and private health care could have a major impact on improved health outcomes, especially as the private sector is so widely used in low and middle income countries. For example, almost three quarters and half of children from the poorest households of South Asia and sub-Saharan Africa, respectively, seek health care from a private provider when they are ill. Private providers are also increasingly responsible for outpatient care for non-communicable diseases.
As a result of the mixed health care system in many low and middle income countries, adequate oversight and stewardship of the mixed system from the national government is essential yet often missing.
Why Was This Study Done?
An understanding of how quality and performance in the private sector compares with that in the public sector would help governments to prioritize where they need to concentrate their efforts. So, for example, if the private sector is generally providing poorer quality care than the public sector, then there is an imperative to improve the quality and outcomes; on the other hand, if the quality of care offered by the private sector is good, the policy priority is to influence the market to further improve access to such health care for low income groups.
In order to help with this comparison, the researchers wanted to systematically identify and summarize the results of studies that directly compared the quality of care offered by public providers with the one offered by “formal” private providers (recognized by law) and “informal” private providers (providers that are not legally recognized, such as lay health workers and shop keepers). For the purposes of this study the researchers focused their comparison on the private and public provision of outpatient care in low and middle income countries.
What Did the Researchers Do and Find?
In their literature review, the researchers searched for relevant studies reported in English, French, or German and published between January 1970 and April 2009. Only studies that compared private and public outpatient medical services in the same country, at the same time, using the same methods, and which met particular quality criteria, were included in the analysis. The researchers also had strict criteria for including qualitative studies, and they retrieved the full text of articles, contacted study authors where appropriate, and verified with a second researcher most (80%) of the extracted study data. In order to evaluate and compare the studies, the researchers converted study values to a linear 100% scale, calculated differences between providers within studies, and summarized the median values of the differences across studies.
The researchers identified a total of 8,812 relevant titles and abstracts and found 80 studies that included direct quantitative comparisons of public and private formal providers. Ten studies included qualitative data. Most studies were conducted after 1990, and mainly in sub-Saharan Africa (n = 39) and Asia and the Pacific (n = 23). Most studies did not report socio-economic status of public and private service users, and only five studies presented data by different income groups. No study compared the same individual providers working in public and private care settings. Only two studies compared public providers and private informal providers, so the authors excluded these from subsequent analysis.
For the formal sector, since the results for “for-profit” and “not-for-profit” providers were similar, the researchers decided to combine the results. Overall, the researchers found that the median values indicated that many services, irrespective of whether public or private, scored low (less than 50%) on infrastructure, clinical competence, and practice. Generally, the private sector performed better in relation to drug supply, responsiveness, and effort, but there was no detectable difference between provider groups for patient satisfaction. Furthermore, a synthesis of qualitative data suggested that the private sector may be more client-centered.
What Do These Findings Mean?
Based on the findings of this review, there is a clear need to consider the quality of primary health services in both the public and private sector in order to improve health outcomes in low and middle income countries. These findings also indicate that, for some aspects of care, on average the private sector provided better quality services. The overall low quality of care in both the formal private and public sector found in this review is worrying, and calls for the governments of low and middle income countries to find and implement effective strategies to improve the quality in both sectors. This is particularly important given the increasing volume of conditions that require relatively sophisticated, long-term ambulatory medical care, such as non-communicable diseases.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000433.
This study is further discussed in a PLoS Medicine Perspective by Jishnu Das
WHO has more information on health service delivery in low- and middle-income countries
WHO has more information on noncommunicable diseases
The World Bank's World Development Report for 2004 addresses health care for poor people
doi:10.1371/journal.pmed.1000433
PMCID: PMC3075233  PMID: 21532746
8.  “Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents 
PLoS Medicine  2010;7(1):e1000202.
Katherine Smith and colleagues investigate the ways in which British American Tobacco influenced the European Union Treaty so that new EU policies advance the interests of major corporations, including those that produce products damaging to health.
Background
Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA.
Methods and Findings
In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost–benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health.
Conclusions
Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The primary goal of public health, the branch of medicine concerned with the health of communities, is to improve lives by preventing disease. Public-health groups do this by assessing and monitoring the health of communities, by ensuring that populations have access to appropriate and cost-effective health care, and by helping to formulate public policies that safeguard human health. Until recently, most of the world's major public-health concerns related to infectious diseases. Nowadays, however, many major public-health concerns are linked to the goods made and marketed by large corporations such as fast food, alcohol, tobacco, and chemicals. In Europe, these corporations are regulated by policies drawn up both by member states and by the European Commission, the executive organ of the European Union (EU; an economic and political partnership among 27 democratic European countries). Thus, for example, the tobacco industry, which is widely recognized as a driver of the smoking epidemic, is regulated by Europe-wide tobacco control policies and member state level policies.
Why Was This Study Done?
Since 1997, the European Commission has been required by law to assess the economic, social (including health), and environmental consequences of new policy initiatives using a process called an “impact assessment” (IA). Because different types of IA examine the likely effects of policies on different aspects of daily life—a health impact assessment, for example, focuses on a policy's effect on health—the choice of IA can lead to different decisions being taken about new policies. Although the IA tool adopted by the European Commission aims to assess economic, environmental and social impacts, independent experts suggest this tool does not adequately assess health impacts. Instead, economic impacts receive the most attention, a situation that may favour the interests of large businesses. In this study, the researchers seek to identify how and why the EU's approach to IA developed. More specifically, the researchers analyze internal documents from British American Tobacco (BAT), which have been disclosed because of US litigation cases, to find out whether industry has played a role in promoting the EU's system of IA.
What Did the Researchers Do and Find?
The researchers analyzed 714 BAT internal documents (identified by searching the Legacy Tobacco Documents Library, which contains more than 10 million internal tobacco company documents) that concerned attempts made by BAT to influence regulatory reforms in Europe. They also analyzed related literature from other sources (for example, academic publications) and interviewed 16 relevant people (including people who had worked at the European Commission). This analysis shows that from 1995, BAT worked with other businesses to promote European regulatory reforms (in particular, the establishment of a business-orientated form of IA) that favor large corporations. A lobbying campaign, initiated by BAT but involving a “policy network” of other companies, first helped to secure binding changes to the EU Treaty that require policymakers to minimize legislative burdens on businesses. The analysis shows that after achieving this goal, which BAT described as an “important victory,” further lobbying ensured that these treaty changes were translated into the implementation of a business-orientated form of IA within the EU. Both the tobacco industry and the chemical industry, the researchers argue, have since used the IA to delay and/or weaken EU legislation intended to protect public health.
What Do These Findings Mean?
These findings suggest that BAT and its corporate allies have fundamentally altered the way in which EU policy is made by ensuring that all significant EU policy decisions have to be assessed using a business-orientated IA. As the authors note, this situation increases the likelihood that the EU will produce policies that favor big business rather than the health of its citizens. Furthermore, these findings suggest that by establishing a network of other industries to help in lobbying for EU Treaty changes, BAT was able to distance itself from the push to establish a business-orientated IA to the extent that Commission officials were unaware of the involvement of the tobacco industry in campaigns for IA. Thus, in future, to safeguard public health, policymakers and public-health groups must pay more attention to corporate efforts to shape decision-making processes. In addition, public-health groups must take account of the ways in which IA can be used to undermine as well as support effective public-health policies and they must collaborate more closely in their efforts to ensure effective national and international policy.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/0.1371/journal.pmed.1000202.
Wikipedia has a page on public health (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
More information on the European Union (in several languages), on public health in the European Union, and on impact assessment by the European Commission is available
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages)
The Smoke Free Partnership contains more information about smoking prevalence in Europe and about European policies to tackle the public health issues associated with tobacco use
For more information about tobacco industry influence on policy see the 2009 World Health Organization report on tobacco industry interference with tobacco control
doi:10.1371/journal.pmed.1000202
PMCID: PMC2797088  PMID: 20084098
9.  Global Health Governance and the Commercial Sector: A Documentary Analysis of Tobacco Company Strategies to Influence the WHO Framework Convention on Tobacco Control 
PLoS Medicine  2012;9(6):e1001249.
Heide Weishaar and colleagues did an analysis of internal tobacco industry documents together with other data and describe the industry's strategic response to the proposed World Health Organization Framework Convention on Tobacco Control.
Background
In successfully negotiating the Framework Convention on Tobacco Control (FCTC), the World Health Organization (WHO) has led a significant innovation in global health governance, helping to transform international tobacco control. This article provides the first comprehensive review of the diverse campaign initiated by transnational tobacco corporations (TTCs) to try to undermine the proposed convention.
Methods and Findings
The article is primarily based on an analysis of internal tobacco industry documents made public through litigation, triangulated with data from official documentation relating to the FCTC process and websites of relevant organisations. It is also informed by a comprehensive review of previous studies concerning tobacco industry efforts to influence the FCTC. The findings demonstrate that the industry's strategic response to the proposed WHO convention was two-fold. First, arguments and frames were developed to challenge the FCTC, including: claiming there would be damaging economic consequences; depicting tobacco control as an agenda promoted by high-income countries; alleging the treaty conflicted with trade agreements, “good governance,” and national sovereignty; questioning WHO's mandate; claiming the FCTC would set a precedent for issues beyond tobacco; and presenting corporate social responsibility (CSR) as an alternative. Second, multiple tactics were employed to promote and increase the impact of these arguments, including: directly targeting FCTC delegations and relevant political actors, enlisting diverse allies (e.g., mass media outlets and scientists), and using stakeholder consultation to delay decisions and secure industry participation.
Conclusions
TTCs' efforts to undermine the FCTC were comprehensive, demonstrating the global application of tactics that TTCs have previously been found to have employed nationally and further included arguments against the FCTC as a key initiative in global health governance. Awareness of these strategies can help guard against industry efforts to disrupt the implementation of the FCTC and support the development of future, comparable initiatives in global health.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die worldwide from tobacco-related causes and, if current trends continue, annual deaths from tobacco-related causes will increase to 10 million by 2030. In response to this global tobacco epidemic, the World Health Organization (WHO) has developed an international instrument for tobacco control called the Framework Convention on Tobacco Control (FCTC). Negotiations on the FCTC began in 1999, and the international treaty—the first to be negotiated under the auspices of WHO—entered into force on 27 February 2005. To date, 174 countries have become parties to the FCTC. As such, they agree to implement comprehensive bans on tobacco advertising, promotion, and sponsorship; to ban misleading and deceptive terms on cigarette packaging; to implement health warnings on tobacco packaging; to protect people from tobacco smoke exposure in public spaces and indoor workplaces; to implement taxation policies aimed at reducing tobacco consumption; and to combat illicit trade in tobacco products.
Why Was This Study Done?
Transnational tobacco corporations (TTCs) are sometimes described as “vectors” of the global tobacco epidemic because of their drive to maximize shareholder value and tobacco consumption. Just like conventional disease vectors (agents that carry or transmit infectious organisms), TTCs employ a variety of tactics to ensure the spread of tobacco consumption. For example, various studies have shown that TTCs have developed strategies that attempt to limit the impact of tobacco control measures such as the FCTC. However, to date, studies investigating the influence of TTCs on the FCTC have concentrated on specific countries or documented specific tactics. Here, the researchers undertake a comprehensive review of the diverse tactics employed by TTCs to undermine the development of the FCTC. Such a review is important because its results should facilitate the effective implementation of FCTC measures and could support the development of future tobacco control initiatives and of global initiatives designed to control alcohol-related and food-related disease and death.
What Did the Researchers Do and Find?
The researchers analyzed documents retrieved from the Legacy Tobacco Documents Library (a collection of internal tobacco industry documents released as a result of US litigation cases) dealing with the strategies employed by TTCs to influence the FCTC alongside data from the websites of industry, consultancy, and other organizations cited in the documents; the official records of the FCTC process; and previous studies of tobacco industry efforts to influence the FCTC. Their analysis reveals that the strategic response of the major TTCs to the proposed FCTC was two-fold. First, the TTCs developed a series of arguments and “frames” (beliefs and ideas that provide a framework for thinking about an issue) to challenge the FCTC. Core frames included claiming that the FCTC would have damaging economic consequences, questioning WHO's mandate to develop a legally binding international treaty by claiming that tobacco was not a cross-border problem, and presenting corporate social responsibility (the commitment by business to affect the environment, consumers, employees, and society positively in addition to making money for shareholders) as an alternative to the FCTC. Second, the TTCs employed multiple strategies to promote and increase the impact of these arguments and frames, such as targeting FCTC delegations and enlisting the help of diverse allies including media outlets and scientists.
What Do These Findings Mean?
These findings illustrate the variety and complexity of the tobacco industry's efforts to undermine the FCTC and show the extent to which TTCs combined and coordinated tactics on a global stage that they had previously used on a national stage. Indeed, “the comprehensiveness and scale of the tobacco industry's response to the FCTC suggests that it is reasonable to speak of a ‘globalisation of tobacco industry strategy’ in combating the development of effective tobacco control policies,” write the researchers. Awareness of the strategies employed by TTCs to influence the FCTC should help guard against industry efforts to disrupt the implementation of the FCTC and should support the development of future global tobacco control initiatives. More generally, these findings should support the development of global health initiatives designed to tackle cardiovascular disease, cancer, chronic respiratory diseases and diabetes – non-communicable diseases that together account for 60% of global deaths and are partly driven by the commercial activities of food, alcohol, and tobacco corporations.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001249.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about the Framework Convention on Tobacco Control
For information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
The Framework Convention Alliance provides more information about the FCTC
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking and not start again
doi:10.1371/journal.pmed.1001249
PMCID: PMC3383743  PMID: 22745607
10.  Configuring Balanced Scorecards for Measuring Health System Performance: Evidence from 5 Years' Evaluation in Afghanistan 
PLoS Medicine  2011;8(7):e1001066.
Anbrasi Edward and colleagues report the results of a balanced scorecard performance system used to examine 29 key performance indicators over a 5-year period in Afghanistan, between 2004 and 2008.
Background
In 2004, Afghanistan pioneered a balanced scorecard (BSC) performance system to manage the delivery of primary health care services. This study examines the trends of 29 key performance indicators over a 5-year period between 2004 and 2008.
Methods and Findings
Independent evaluations of performance in six domains were conducted annually through 5,500 patient observations and exit interviews and 1,500 provider interviews in >600 facilities selected by stratified random sampling in each province. Generalized estimating equation (GEE) models were used to assess trends in BSC parameters. There was a progressive improvement in the national median scores scaled from 0–100 between 2004 and 2008 in all six domains: patient and community satisfaction of services (65.3–84.5, p<0.0001); provider satisfaction (65.4–79.2, p<0.01); capacity for service provision (47.4–76.4, p<0.0001); quality of services (40.5–67.4, p<0.0001); and overall vision for pro-poor and pro-female health services (52.0–52.6). The financial domain also showed improvement until 2007 (84.4–95.7, p<0.01), after which user fees were eliminated. By 2008, all provinces achieved the upper benchmark of national median set in 2004.
Conclusions
The BSC has been successfully employed to assess and improve health service capacity and service delivery using performance benchmarking during the 5-year period. However, scorecard reconfigurations are needed to integrate effectiveness and efficiency measures and accommodate changes in health systems policy and strategy architecture to ensure its continued relevance and effectiveness as a comprehensive health system performance measure. The process of BSC design and implementation can serve as a valuable prototype for health policy planners managing performance in similar health care contexts.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Traditionally, the performance of a health system (the complete network of health care agencies, facilities, and providers in a defined geographical region) has been measured in terms of health outcomes: how many people have been treated, how many got better, and how many died. But, nowadays, with increased demand for improved governance and accountability, policy makers are seeking comprehensive performance measures that show in detail how innovations designed to strengthen health systems are affecting service delivery and health outcomes. One such performance measure is the “balanced scorecard,” an integrated management and measurement tool that enables organizations to clarify their vision and strategy and translate them into action. The balanced scorecard—essentially a list of key performance indicators and performance benchmarks in several domains—was originally developed for industry but is now becoming a popular strategic management tool in the health sector. For example, balanced scorecards have been successfully integrated into the Dutch and Italian public health care systems.
Why Was This Study Done?
Little is known about the use of balanced scorecards in the national public health care systems of developing countries but the introduction of performance management into health system reform in fragile states in particular (developing countries where the state fails to perform the fundamental functions necessary to meet its citizens' basic needs and expectations) could help to promote governance and leadership, and facilitate essential policy changes. One fragile state that has introduced the balanced scorecard system for public health care management is Afghanistan, which emerged from decades of conflict in 2002 with some of the world's worst health indicators. To deal with an extremely high burden of disease, the Ministry of Public Health (MOPH) designed a Basic Package of Health Services (BPHS), which is delivered by nongovernmental organizations and MOPH agencies. In 2004, the MOPH introduced the National Health Service Performance Assessment (NHSPA), an annual country-wide assessment of service provision and patient satisfaction and pioneered a balanced scorecard, which uses data collected in the NHSPA, to manage the delivery of primary health care services. In this study, the researchers examine the trends between 2004 and 2008 of the 29 key performance indicators in six domains included in this balanced scorecard, and consider the potential and limitations of the scorecard as a management tool to measure and improve health service delivery in Afghanistan and other similar countries.
What Did the Researchers Do and Find?
Each year of the study, a random sample of 25 facilities (district hospitals and comprehensive and basic health centers) in 28 of Afghanistan's 34 provinces was chosen (one province did not have functional facilities in 2004 and the other five missing provinces were inaccessible because of ongoing conflicts). NHSPA surveyors collected approximately 5,000 patient observations, 5,000 exit interviews with patients or their caregivers, and 1,500 health provider interviews by observing consultations involving five children under 5 years old and five patients over 5 years old in each facility. The researchers then used this information to evaluate the key performance indicators in the balanced scorecard and a statistical method called generalized estimating equation modeling to assess trends in these indicators. They report that there was a progressive improvement in national average scores in all six domains (patients and community satisfaction with services, provider satisfaction, capacity for service provision, quality of services, overall vision for pro-poor and pro-female health services, and financial systems) between 2004 and 2008.
What Do These Findings Mean?
These findings suggest that the balanced scorecard was successfully used to improve health system capacity and service delivery through performance benchmarking over the 5-year study period. Importantly, the use of the balanced scorecard helped to show the effects of investments, facilitate policy change, and create a more evidence-based decision-making culture in Afghanistan's primary health care system. However, the researchers warn that the continuing success of the balanced scorecard in Afghanistan will depend on its ability to accommodate changes in health systems policy. Furthermore, reconfigurations of the scorecard are needed to include measures of the overall effectiveness and efficiency of the health system such as mortality rates. More generally, the researchers conclude that the balanced scorecard offers a promising measure of health system performance that could be used to examine the effectiveness of health care strategies and innovations in other fragile and developing countries.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001066.
A 2010 article entitled An Afghan Success Story: The Balanced Scorecard and Improved Health Services in The Globe, a newsletter produced by the Department of International Health at the John Hopkins Bloomberg School of Public Health, provides a detailed description of the balanced scorecard used in this study
Wikipedia has a page on health systems and on balanced scorecards (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The World Health Organization country profile of Afghanistan provides information on the country's health system and burden of disease (in several languages)
doi:10.1371/journal.pmed.1001066
PMCID: PMC3144209  PMID: 21814499
11.  “Key to the Future”: British American Tobacco and Cigarette Smuggling in China 
PLoS Medicine  2006;3(7):e228.
Background
Cigarette smuggling is a major public health issue, stimulating increased tobacco consumption and undermining tobacco control measures. China is the ultimate prize among tobacco's emerging markets, and is also believed to have the world's largest cigarette smuggling problem. Previous work has demonstrated the complicity of British American Tobacco (BAT) in this illicit trade within Asia and the former Soviet Union.
Methods and Findings
This paper analyses internal documents of BAT available on site from the Guildford Depository and online from the BAT Document Archive. Documents dating from the early 1900s to 2003 were searched and indexed on a specially designed project database to enable the construction of an historical narrative. Document analysis incorporated several validation techniques within a hermeneutic process. This paper describes the huge scale of this illicit trade in China, amounting to billions of (United States) dollars in sales, and the key supply routes by which it has been conducted. It examines BAT's efforts to optimise earnings by restructuring operations, and controlling the supply chain and pricing of smuggled cigarettes.
Conclusions
Our research shows that smuggling has been strategically critical to BAT's ongoing efforts to penetrate the Chinese market, and to its overall goal to become the leading company within an increasingly global industry. These findings support the need for concerted efforts to strengthen global collaboration to combat cigarette smuggling.
Editors' Summary
Background.
Smoking tobacco kills about 5 million people around the world every year, and according to the World Health Organization, half of the people who smoke will eventually die as a result. The habit is in decline in most of the world's richer nations, but it is growing in developing countries. Governments can control consumption, and raise substantial tax revenues, by levying high taxes on tobacco. However, this is undermined when tobacco is smuggled into the country and sold illegally. Smuggling makes cigarettes more affordable, thus stimulating consumption, and undermines efforts to reduce smoking rates.
  British American Tobacco (BAT) is one of the largest international tobacco companies. Following a legal case in the United States, millions of pages of BAT internal documents (dating back to the early 1900s) have been made public. They are held in a depository in the United Kingdom, and most can now be seen online. Researchers have already undertaken wide-ranging studies of these documents and have drawn conclusions about the way BAT has sought to enter emerging markets throughout the world.
Why Was This Study Done?
Previously published studies have concluded that BAT has been “complicit” in large-scale cigarette smuggling, described in documents by the euphemisms “transit,” “general trade” (“GT”), “duty not paid” (“DNP”), and “free market.” This study focuses on such activities in China, which is believed to have the world's biggest tobacco smuggling problem. China is a key market for BAT and other tobacco companies because of the size of its population, high smoking prevalence, and rapidly growing economy. The development of effective tobacco control policy in China constitutes one of the greatest opportunities to advance global health. The State Tobacco Monopoly Administration is the only agency legally allowed to trade in tobacco in China.
What Did the Researchers Do and Find?
The authors have put together an account of the company's trading in China in the period from 1986 to 1999. They begin by describing the scale on which tobacco was smuggled into China and the main supply routes through which tobacco entered the country. They found evidence that smuggling increased considerably during the period.
  The researchers found that BAT's own documents describe the company's efforts to improve its earnings from China by restructuring operations and controlling the supply chain—that is, how cigarettes are manufactured and legally exported, are handled by various “agents” or middlemen, and then are sold illicitly as contraband. The title of this article is taken from one BAT document that states that exports from Hong Kong to China are the “key to the future” of the company's planned growth. The researchers say that this can be taken to mean smuggling, and that BAT's documents indicate that the company benefited from, encouraged, and attempted to control the smuggling of tobacco into China.
What Do These Findings Mean?
BAT has stated publicly that it does not approve of smuggling. However, from the researchers' analysis of the information in the internal papers, they conclude that “the documents demonstrate that contraband has been a hugely profitable and integral part of BAT operations in China over the past two decades.” They estimate that the value of the illicit trade amounts to billions of (United States) dollars and go on to say that “for the Chinese government, this illicit trade undermined restrictions on imports, represented an enormous loss of tax revenue, and stimulated demand for premium brand cigarettes.” The researchers argue that action should be taken internationally to reduce tobacco smuggling.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030228.
• Most of the documents used in this paper can be found at the British American Tobacco Documents Archive created by public health researchers (the Web site also contains useful information on tobacco document research)
• The Tobacco Free Initiative, based at the World Health Organization, provides information on the global scale of the tobacco problem, and about efforts to combat the situation
• Many countries have national anti-smoking organizations; the United Kingdom charity Action on Smoking and Health has a useful list of these
• Information about the dangers of smoking to personal health and advice on giving up the habit are available from the Web sites of the American Academy of Family Physicians and NHS Direct (United Kingdom National Health Service)
Internal documents from British American Tobacco demonstrate the scale of tobacco smuggling into China and show that this illicit trade has been a critical factor in BAT's expansion in this market.
doi:10.1371/journal.pmed.0030228
PMCID: PMC1502159  PMID: 16834455
12.  Tobacco Company Efforts to Influence the Food and Drug Administration-Commissioned Institute of Medicine Report Clearing the Smoke: An Analysis of Documents Released through Litigation 
PLoS Medicine  2013;10(5):e1001450.
Stanton Glantz and colleagues investigate efforts by tobacco companies to influence Clearing the Smoke, a 2001 Institute of Medicine report on harm reduction tobacco products.
Please see later in the article for the Editors' Summary
Background
Spurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco “harm reduction,” leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report.
Methods and Findings
We analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes (“substantial equivalence”) without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act.
Conclusions
Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Up to half of tobacco users will die of cancer, lung disease, heart disease, stroke, or another tobacco-related disease. Cigarettes and other tobacco products cause disease because they expose their users to nicotine and numerous other toxic chemicals. Tobacco companies have been working to develop a “safe” cigarette for more than half a century. Initially, their attention focused on cigarettes that produced lower tar and nicotine yields in machine-smoking tests. These products were perceived as “safer” products by the public and scientists for many years, but it is now known that the use of low-yield cigarettes can actually expose smokers to higher levels of toxins than standard cigarettes. More recently, the tobacco companies have developed other products (for example, products that heat aerosols of nicotine, rather than burning the tobacco) that claim to reduce harm and the risk of tobacco-related disease, but they can only market these modified risk tobacco products in the US after obtaining Food and Drug Administration (FDA) approval. In 1999, the FDA commissioned the US Institute of Medicine (IOM, an influential source of independent expert advice on medical issues) to assess the science base for tobacco “harm reduction.” In 2001, the IOM published its report Clearing the Smoke: Assessing the Science Base for Tobacco Harm and Reduction, which, although controversial, set the tone for the development and regulation of tobacco products in the US, particularly those claiming to be less dangerous, in subsequent years.
Why Was This Study Done?
Tobacco companies have a long history of working to shape scientific discussions and agendas. For example, they have produced research results designed to “create controversy” about the dangers of smoking and secondhand smoke. In this study, the researchers investigate how tobacco companies organized to try to influence the IOM committee that prepared the Clearing the Smoke report on modified risk tobacco products by analyzing tobacco industry and IOM documents.
What Did the Researchers Do and Find?
The researchers searched the Legacy Tobacco Documents Library (a collection of internal tobacco industry documents released as a result of US litigation cases) for documents outlining how tobacco companies tried to influence the IOM Committee to Assess the Science Base for Tobacco Harm Reduction and created a timeline of events from the 1,000 or so documents they retrieved. They confirmed and supplemented this timeline using information in 80 files that detailed written interactions between the tobacco companies and the IOM committee, which they obtained through a public records access request. Analysis of these documents indicates that the tobacco companies considered the IOM report to have important regulatory implications, that they developed and implemented strategies with consulting and legal firms to access the IOM proceedings, and that tobacco company lawyers, consultants, and regulatory staff shaped presentations to the IOM committee by company scientists on various aspects of tobacco harm reduction products. The analysis also shows that tobacco companies were pleased with the final report, particularly its recommendation that tobacco products can be marketed with exposure or risk reduction claims provided the products substantially reduce exposure and provided the behavioral and health consequences of these products are determined in post-marketing surveillance and epidemiological studies (“tiered testing”) and its recommendation that, provided no claim of reduced exposure or risk is made, new products comparable to existing conventional cigarettes (“substantial equivalence”) can be marketed without prior regulatory approval.
What Do These Findings Mean?
These findings suggest that tobacco companies used their legal and regulatory staff to access the IOM committee that advised the FDA on modified risk tobacco products and that they used this access to deliver specific, carefully formulated messages designed to serve their business interests. Although these findings provide no evidence that the efforts of tobacco companies influenced the IOM committee in any way, they show that the companies were satisfied with the final IOM report and its recommendations, some of which have policy implications that continue to reverberate today. The researchers therefore call for the FDA and other regulatory bodies to remember that they are dealing with companies with a long history of intentionally misleading the public when assessing the information presented by tobacco companies as part of the regulatory process and to actively protect their public-health policies from the commercial interests of the tobacco industry.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001450.
This study is further discussed in a PLOS Medicine Perspective by Thomas Novotny
The World Health Organization provides information about the dangers of tobacco (in several languages); for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
A PLOS Medicine Research Article by Heide Weishaar and colleagues describes tobacco company efforts to undermine the Framework Convention on Tobacco Control, an international instrument for tobacco control
Wikipedia has a page on tobacco harm reduction (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The IOM report Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction is available to read online
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The University of California, San Francisco Center for Tobacco Control Research and Education is the focal point for University of California, San Francisco (UCSF) scientists in disciplines ranging from the molecular biology of nicotine addiction through political science who combine their efforts to eradicate the use of tobacco and tobacco-induced cancer and other diseases worldwide
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001450
PMCID: PMC3665841  PMID: 23723740
13.  Driving a decade of change: HIV/AIDS, patents and access to medicines for all 
Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines.
Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization's Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale.
Despite these changes, however, a "treatment timebomb" awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required.
One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a broad set of policies needed to ensure access to medicines for all; other key measures include sufficient and reliable financing, research and development of new products targeted for use in resource-poor settings, and use of patent law flexibilities. Governments must live up to their obligations to protect access to medicines as a fundamental component of the human right to health.
doi:10.1186/1758-2652-14-15
PMCID: PMC3078828  PMID: 21439089
14.  Medicine, Media Communication and Ethical Aspects 
Materia Socio-Medica  2010;22(1):6-13.
Summary
On World Press Freedom Day (3rd of May 2009) details of the Frida Haus ranking list of press freedom in countries around the world were officially disclosed. Bosnia and Herzegovina is ranked at 98 place, and in the region better ranked is only Montenegro, which is located between 78 and 80 place along with Botswana and Eastern Timor. Top rated is Iceland with 9 points and on the last place is North Korea, with 98 points. Almost every profession has its deontology/ethical principles. However, medicine and the media are specifically targeted by public controversy with regard to the consequences of their responsibilities for the individual and the overall population. Until twenty years ago, the media were the main social system or a reflection of the social system and dominated the field of public communication, which implicitly reflected in the organization, operation and effects of companies, corporations, etc. as the overall social system, increasing the gross national product and its various categories enabled boom. Medicine and health represent to a wide range of people, perhaps, the most interesting source of information, and probably there isn’t a person that once was not interested in quality professional and verified information regarding some of their medical condition or overall health status. It is estimated that today there are more than a million Web sites on health and diseases, which means that the availability of health information for users is better today than ever before. However, it is important to patients and users of web sites with health information to learn how to properly use them, and learn to assess whether the information published on this site are of reliable quality, which depends on the authors who put the information on the web site, their topicality, simplicity in use and especially the diversity of the medical content of these web pages. It is the Internet that allows the revolution in relation patient-health care- health services provider. First look is at the symptoms and other health information on the Internet before patients actually go to the doctor. In response to this there is change in the relation patient- doctor, there are attempts to allow the patient to make a test, for example, cholesterol in the blood prior to scheduling the examination by the doctor. The vision of the future is Web-based and secure health record (Medical Record) that can be maintained in some kind of health plan or supervised by a physician. Such a site can be used when the patient is traveling or when he or she goes to the pharmacy or doctor of any specialty. Access to appropriate information may strengthen patients to express their demands and medical professionalism in order to improve clinical decision making. Information on support of patients and their involvement in prevention, alternative treatments and their care should be a central part of quality improvement strategies. Improving the quality of information and helping people use the most of what is offered have to be realized by implementing the strategies. Governments should invest in public education programs to encourage people to critically evaluate health information. For their share, they will have to be aware of the scope and quality of information sources that can be used by patients, so that they can get advice from them in an appropriate manner.
doi:10.5455/msm.2010.22.6-13
PMCID: PMC3813544  PMID: 24493979
media; medicine; ethical aspects
15.  Corporate Social Responsibility and Access to Policy Élites: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2011;8(8):e1001076.
Gary Fooks and colleagues undertook a review of tobacco industry documents and show that policies on corporate social responsibility can enable access to and dialogue with policymakers at the highest level.
Background
Recent attempts by large tobacco companies to represent themselves as socially responsible have been widely dismissed as image management. Existing research supports such claims by pointing to the failings and misleading nature of corporate social responsibility (CSR) initiatives. However, few studies have focused in depth on what tobacco companies hoped to achieve through CSR or reflected on the extent to which these ambitions have been realised.
Methods and Findings
Iterative searching relating to CSR strategies was undertaken of internal British American Tobacco (BAT) documents, released through litigation in the US. Relevant documents (764) were indexed and qualitatively analysed. In the past decade, BAT has actively developed a wide-ranging CSR programme. Company documents indicate that one of the key aims of this programme was to help the company secure access to policymakers and, thereby, increase the company's chances of influencing policy decisions. Taking the UK as a case study, this paper demonstrates the way in which CSR can be used to renew and maintain dialogue with policymakers, even in ostensibly unreceptive political contexts. In practice, the impact of this political use of CSR is likely to be context specific; depending on factors such as policy élites' understanding of the credibility of companies as a reliable source of information.
Conclusions
The findings suggest that tobacco company CSR strategies can enable access to and dialogue with policymakers and provide opportunities for issue definition. CSR should therefore be seen as a form of corporate political activity. This underlines the need for broad implementation of Article 5.3 of the Framework Convention on Tobacco Control. Measures are needed to ensure transparency of interactions between all parts of government and the tobacco industry and for policy makers to be made more aware of what companies hope to achieve through CSR.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In the past, companies and multinational corporations were judged on the profits they made. Nowadays, though, much is made of corporate social responsibility (CSR). CSR is the commitment by business to behave ethically and to contribute to economic development while improving the quality of life of the workforce, their families, the local community, and society at large. Put simply, companies and corporations now endeavor to show that they have a positive impact on the environment, consumers, employees, and society in addition to making money for their shareholders. Large tobacco companies are no exception. British American Tobacco (BAT, the world's second largest publicly traded tobacco company), for example, began working on a wide-ranging CSR program more than a decade ago. Given that tobacco is responsible for an estimated 5.4 million deaths worldwide annually, this program was initially met with hostility and dismissed as an image management exercise. However, large parts of the investment and CSR communities now approve of BAT's CSR program, which has won numerous awards.
Why Was This Study Done?
But what do BAT and other tobacco companies actually hope to achieve through their CSR initiatives and how successful have they been in achieving these aims? Few studies have addressed these important questions. In particular, there has been little research into the extent to which tobacco companies use CSR initiatives as a form of corporate political activity that can help them gain “access” to policymakers and define the legitimate concerns and optimal alternatives of public policy (“issue definition”). Access is defined as taking place when policymakers consider the views of policy advocates such as tobacco company employees and is a crucial component of issue definition, which refers to the strategies adopted by bodies such as multinational corporations to influence the policy agenda by defining what issues public policy should concern itself with and how it should approach them. In this case study, the researchers explore whether BAT's CSR program works as a form of corporate political activity by systematically examining internal BAT documents made publicly available as a result of US litigation. Specifically, the researchers examine BAT's efforts through its CSR program to reestablish access with the UK Department of Health following the department's decision in the late 1990s to restrict contact with major tobacco companies.
What Did the Researchers Do and Find?
Using iterative searching, the researchers identified 764 documents in the Legacy Tobacco Documents Library (a large collection of internal tobacco company documents released as a result of US litigation cases) that contain information relevant to BAT's CSR strategies. Their analysis of these documents indicates that one of the key aims of the CSR program actively developed over the past decade by BAT was to help secure access to policymakers and shows how BAT used CSR to renew and maintain dialogue with policymakers at a time when contact between government and tobacco companies was extremely restricted. The documents also show that BAT employees used CSR initiatives as a means of issue definition to both optimize the probability of subsequent discussions taking place and to frame their content. Finally, the documents illustrate how BAT used its CSR program to expand the number of access points across government, thereby providing BAT with more opportunities to meet and talk to officials.
What Do These Findings Mean?
These findings suggest that CSR is a form of corporate political activity that potentially has important implications for public health given the documented impact of the political activity of tobacco companies in delaying and blocking health-related tobacco control policies. In practice, the impact of the political use of CSR is likely to be context specific and will depend on factors such as whether senior policymakers regard companies as reliable sources of information. Importantly, these findings underline the need for broad implementation of Article 5.3 of the World Health Organization's Framework Convention on Tobacco Control (FCTC), an international treaty that calls for the introduction of multiple measures to reduce tobacco consumption, including tobacco advertizing bans and relevant taxation policies. Article 5.3 aims to protect public-health policies on tobacco control from tobacco industry influence. The findings of this study indicate that implementation of Article 5.3 will require measures that ensure transparency in interactions between all parts of government and the tobacco industry and will need an increased awareness across government of what tobacco companies hope to achieve through CSR.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001076.
The Corporate Responsibility (CORE) coalition, an alliance of voluntary organizations, trade unions, and companies, maintains a Web site that contains useful material on corporate social responsibility
The European Coalition for Corporate Justice (ECCJ) promotes corporate accountability by bringing together national platforms of civil society organizations (including NGOs, trade unions, consumer advocacy groups, and academic institutions) from all over Europe
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages), details of the Framework Convention on Tobacco Control (in several languages), and guidelines for the implementation of Article 5.3 of the FCTC
The Framework Convention Alliance provides more information about the FCTC
For information about tobacco industry influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
doi:10.1371/journal.pmed.1001076
PMCID: PMC3160341  PMID: 21886485
16.  A Case Analysis of INFOMED: The Cuban National Health Care Telecommunications Network and Portal 
Background
The Internet and telecommunications technologies contribute to national health care system infrastructures and extend global health care services markets. The Cuban national health care system offers a model to show how a national information portal can contribute to system integration, including research, education, and service delivery as well as international trade in products and services.
Objective
The objectives of this paper are (1) to present the context of the Cuban national health care system since the revolution in 1959, (2) to identify virtual institutional infrastructures of the system associated with the Cuban National Health Care Telecommunications Network and Portal (INFOMED), and (3) to show how they contribute to Cuban trade in international health care service markets.
Methods
Qualitative case research methods were used to identify the integrated virtual infrastructure of INFOMED and to show how it reflects socialist ideology. Virtual institutional infrastructures include electronic medical and information services and the structure of national networks linking such services.
Results
Analysis of INFOMED infrastructures shows integration of health care information, research, and education as well as the interface between Cuban national information networks and the global Internet. System control mechanisms include horizontal integration and coordination through virtual institutions linked through INFOMED, and vertical control through the Ministry of Public Health and the government hierarchy. Telecommunications technology serves as a foundation for a dual market structure differentiating domestic services from international trade.
Conclusions
INFOMED is a model of interest for integrating health care information, research, education, and services. The virtual infrastructures linked through INFOMED support the diffusion of Cuban health care products and services in global markets. Transferability of this model is contingent upon ideology and interpretation of values such as individual intellectual property and confidentiality of individual health information. Future research should focus on examination of these issues and their consequences for global markets in health care.
doi:10.2196/jmir.8.1.e1
PMCID: PMC1550691  PMID: 16585025
Case analysis; Cuban national health care system; INFOMED; ideology; virtual infrastructure; health care markets; globalization
17.  Health and Human Rights Concerns of Drug Users in Detention in Guangxi Province, China 
PLoS Medicine  2008;5(12):e234.
Background
Although confinement in drug detoxification (“detox”) and re-education through labor (RTL) centers is the most common form of treatment for drug dependence in China, little has been published about the experience of drug users in such settings. We conducted an assessment of the impact of detention on drug users' access to HIV prevention and treatment services and consequent threats to fundamental human rights protections.
Methods and Findings
Chinese government HIV and anti-narcotics legislation and policy documents were reviewed, and in-depth and key informant interviews were conducted with 19 injection drug users (IDUs) and 20 government and nongovernmental organization officials in Nanning and Baise, Guangxi Province. Significant contradictions were found in HIV and antinarcotics policies, exemplified by the simultaneous expansion of community-based methadone maintenance therapy and the increasing number of drug users detained in detox and RTL center facilities. IDU study participants reported, on average, having used drugs for 14 y (range 8–23 y) and had been confined to detox four times (range one to eight times) and to RTL centers once (range zero to three times). IDUs expressed an intense fear of being recognized by the police and being detained, regardless of current drug use. Key informants and IDUs reported that routine HIV testing, without consent and without disclosure of the result, was the standard policy of detox and RTL center facilities, and that HIV-infected detainees were not routinely provided medical or drug dependency treatment, including antiretroviral therapy. IDUs received little or no information or means of HIV prevention, but reported numerous risk behaviors for HIV transmission while detained.
Conclusions
Legal and policy review, and interviews with recently detained IDUs and key informants in Guangxi Province, China, found evidence of anti-narcotics policies and practices that appear to violate human rights and imperil drug users' health.
Based on their review of Chinese government legislation and policy documents, and using interviews with recently detained injection drug users and officials in Guangxi Province, Elizabeth Cohen and Joseph Amon find evidence of antinarcotics policies and practices that may compromise the health and human rights of drug users.
Editors' Summary
Background.
Ever since the AIDS (acquired immunodeficiency syndrome) epidemic began, needle sharing by injection drug users (IDUs) has been a major transmission route for the human immunodeficiency virus (HIV), the blood-borne virus that causes AIDS. In China, for example, the AIDS epidemic began in earnest in 1989 when 146 HIV-positive IDUs were identified in Southwest Yunnan. By 1998, HIV infections had been reported throughout China, 60%–70% of which were in IDUs. These days, nearly half of new HIV infections in China are associated with injection drug use and 266,000 of the 700,000 HIV-positive people in China are drug users. Faced with these figures, the Chinese government has recently introduced measures to reduce HIV transmission among the estimated 3–4 million IDUs in China. These measures include increased provision of methadone maintenance treatment clinics and needle exchanges and the establishment of HIV prevention programs that target IDUs.
Why Was This Study Done?
Alongside these progressive public-health practices, China has extremely punitive anti-narcotics policies. IDUs are routinely confined without legal review in drug detoxification centers or sent to re-education through labor (RTL) centers, sometimes for many years. In 2005, these centers housed more than 350,000 drug users yet little is known about the conditions in these centers or how the Chinese anti-narcotic policy affects human rights or access to HIV prevention and treatment services. In this study, the researchers investigated these issues by interviewing IDUs and “key informants” (government officials and members of nongovernmental organizations [NGOs] who provide services to IDUs) about their experiences of detoxification centers and RTL centers in two cities in Guangxi Province, China.
What Did the Researchers Do and Find?
The researchers recruited 19 IDUs who had been recently confined in a detoxification center or RTL center and 20 key informants (including a doctor at a detoxification center and a former RTL center guard). In the interviews the researchers used a semi-structured questionnaire to ask the participants about their experiences of detoxification centers and RTL centers. All the IDUs reported that they were repeatedly tested for HIV while in detention but never given their test results even when they asked for them. Key informants confirmed that repeated HIV testing without result disclosure is the current policy in detoxification centers and RTL centers. All the IDUs expressed concerns about inadequate access to health care in detention. In particular, most of the IDUs who were taking antiretroviral drugs before detention were unable to continue their treatment during detention, although two received antiretroviral drugs by negotiating with their guards. The IDUs and key informants also both noted that very little information or means of HIV prevention was provided in the detoxification centers and RTL centers and that HIV-related risk behaviors, including injection drug use and unsafe sex, occurred in both types of center. Finally, the IDUs reported that their fear of being recognized by the police and detained even if not taking drugs prevented them from seeking HIV tests, HIV treatment, and help for their drug addiction.
What Do These Findings Mean?
This study has several limitations in addition to its small size. For example, because the IDUs were self selected—they responded to posters asking if they would be interviewed—their views may not be representative of all IDUs. Similarly, the key informants who were interviewed might have had different opinions from those who chose not to participate. Furthermore, the results reported here cannot be generalized to other areas of China. Nevertheless, the consistent experiences reported by the IDUs and confirmed by the key informants suggest that China's anti-narcotic policies and practices violate the human rights of IDUs and put their health in danger by making it hard for them to access HIV prevention and treatment or adequate treatment for their drug addiction. This situation, if not remedied, is likely to jeopardize China's attempts to control its HIV epidemic.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050234.
This study is further discussed in a PLoS Medicine Perspective by Steve Koester
Avert, an international AIDS charity, provides information on all aspects of HIV/AIDS, including HIV and AIDS in China and HIV prevention, harm reduction, and injecting drug use
The UNAIDS 2008 Country Progress Report provides up-to-date details about the AIDS situation in China
HIVInSite provides links to more information about HIV/AIDS in China.
Human Rights Watch works on health and human rights and human rights developments in China
The US National Institute on Drug Abuse provides a booklet entitled Principles of Drug Addiction Treatment: A Research Based Guide (in English and Spanish)
UN Office on Drugs and Crime has information on HIV/AIDS in prisons
doi:10.1371/journal.pmed.0050234
PMCID: PMC2596857  PMID: 19071954
18.  Canada and access to medicines in developing countries: intellectual property rights first 
Canadian reports have recommended that health as a human right must be Canada’s overarching global commitment and that the primacy of human rights should be prioritized over other elements of international law including international trade and investment law as it applies to access to pharmaceuticals. This paper uses a series of case reports to examine Canada’s commitment to this goal. Specifically it examines cases where improved access has been in conflict with increased intellectual property rights. The 6 cases are: Canada’s position when 39 pharmaceutical companies took South Africa to court in 1998 over its legislation to allow parallel importation of patented medicines and to regulate the price of medications; the stance that Canada took in the negotiations around the Doha Declaration in 2001; the passage of Canada’s Access to Medicines Regime in 2004 and subsequent attempts to amend the legislation in 2011 and 2012; Canada’s involvement in the final declaration at the United Nations High-Level meeting on non-communicable diseases in 2012; Canada’s views about the terms in the Anti-Counterfeiting Trade Agreement as expressed in 2009; and Canada’s 2013 position on the extension of the exemption for least developed countries from having to comply with the terms of the Trade Related Aspects of Intellectual Property Rights Agreement. In the first case Canada was neutral but in the remaining 5 cases Canada prioritized intellectual property rights over access. This position is consistent with how Canada has acted around domestic issues involving intellectual property rights for pharmaceutical products. Canada has supported strengthened rights despite the fact that their touted benefits have not been realized either domestically or in developing countries. As a result Canada has failed in its humanitarian duty to protect the human right to health in the form of safe and low cost medicines for the people in developing countries.
doi:10.1186/1744-8603-9-42
PMCID: PMC3844468  PMID: 24007595
Access; Anti-Counterfeiting Trade Agreement; Canada; Canada’s Access to Medicines Regime; Doha Declaration; Intellectual property rights; Least developed countries; Non-communicable diseases; TRIPS
19.  Analysis of the Security and Privacy Requirements of Cloud-Based Electronic Health Records Systems 
Background
The Cloud Computing paradigm offers eHealth systems the opportunity to enhance the features and functionality that they offer. However, moving patients’ medical information to the Cloud implies several risks in terms of the security and privacy of sensitive health records. In this paper, the risks of hosting Electronic Health Records (EHRs) on the servers of third-party Cloud service providers are reviewed. To protect the confidentiality of patient information and facilitate the process, some suggestions for health care providers are made. Moreover, security issues that Cloud service providers should address in their platforms are considered.
Objective
To show that, before moving patient health records to the Cloud, security and privacy concerns must be considered by both health care providers and Cloud service providers. Security requirements of a generic Cloud service provider are analyzed.
Methods
To study the latest in Cloud-based computing solutions, bibliographic material was obtained mainly from Medline sources. Furthermore, direct contact was made with several Cloud service providers.
Results
Some of the security issues that should be considered by both Cloud service providers and their health care customers are role-based access, network security mechanisms, data encryption, digital signatures, and access monitoring. Furthermore, to guarantee the safety of the information and comply with privacy policies, the Cloud service provider must be compliant with various certifications and third-party requirements, such as SAS70 Type II, PCI DSS Level 1, ISO 27001, and the US Federal Information Security Management Act (FISMA).
Conclusions
Storing sensitive information such as EHRs in the Cloud means that precautions must be taken to ensure the safety and confidentiality of the data. A relationship built on trust with the Cloud service provider is essential to ensure a transparent process. Cloud service providers must make certain that all security mechanisms are in place to avoid unauthorized access and data breaches. Patients must be kept informed about how their data are being managed.
doi:10.2196/jmir.2494
PMCID: PMC3757992  PMID: 23965254
cloud-computing; eHealth; electronic health records (EHRs); privacy; security
20.  Transnational Tobacco Company Interests in Smokeless Tobacco in Europe: Analysis of Internal Industry Documents and Contemporary Industry Materials 
PLoS Medicine  2013;10(9):e1001506.
In light lobbying by transnational tobacco companies to remove the European Union ban on the sale of snus (a smokeless tobacco product), Silvy Peeters and Anna Gilmore explore the motivation behind tobacco companies' interests in smokeless tobacco products in Europe.
Please see later in the article for the Editors' Summary
Background
European Union (EU) legislation bans the sale of snus, a smokeless tobacco (SLT) which is considerably less harmful than smoking, in all EU countries other than Sweden. To inform the current review of this legislation, this paper aims to explore transnational tobacco company (TTC) interests in SLT and pure nicotine in Europe from the 1970s to the present, comparing them with TTCs' public claims of support for harm reduction.
Methods and Results
Internal tobacco industry documents (in total 416 documents dating from 1971 to 2009), obtained via searching the online Legacy Tobacco Documents Library, were analysed using a hermeneutic approach. This library comprises documents obtained via litigation in the US and does not include documents from Imperial Tobacco, Japan Tobacco International, or Swedish Match. To help overcome this limitation and provide more recent data, we triangulated our documentary findings with contemporary documentation including TTC investor presentations. The analysis demonstrates that British American Tobacco explored SLT opportunities in Europe from 1971 driven by regulatory threats and health concerns, both likely to impact cigarette sales negatively, and the potential to create a new form of tobacco use among those no longer interested in taking up smoking. Young people were a key target. TTCs did not, however, make SLT investments until 2002, a time when EU cigarette volumes started declining, smoke-free legislation was being introduced, and public health became interested in harm reduction. All TTCs have now invested in snus (and recently in pure nicotine), yet both early and recent snus test markets appear to have failed, and little evidence was found in TTCs' corporate materials that snus is central to their business strategy.
Conclusions
There is clear evidence that BAT's early interest in introducing SLT in Europe was based on the potential for creating an alternative form of tobacco use in light of declining cigarette sales and social restrictions on smoking, with young people a key target. We conclude that by investing in snus, and recently nicotine, TTCs have eliminated competition between cigarettes and lower-risk products, thus helping maintain the current market balance in favour of (highly profitable) cigarettes while ensuring TTCs' long-term future should cigarette sales decline further and profit margins be eroded.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die from cancer, heart disease, and other tobacco-related diseases. In recent years, to reduce this growing loss of life, international and national bodies have drawn up various tobacco control conventions and directives. For example, the European Union (EU) Directives on tobacco control call for member states to ban tobacco advertising, promotion, and sponsorship and to adopt taxation policies aimed at reducing tobacco consumption. The 2001 EU Tobacco Products Directive also bans the sale of snus, a form of smokeless tobacco (SLT), in all EU countries except Sweden. Snus, which originated in Sweden in the early 19th century, is a moist tobacco product that is placed under the upper lip. Although snus is considerably less harmful than smoking, the sale of snus was banned in the EU in 1992 because of fears that it might cause cancer and was being marketed to young people. When Sweden joined the EU in 1994, exemption from the ban was made a condition of the membership treaty.
Why Was This Study Done?
Transnational tobacco companies (TTCs) have been investing in European snus manufacturers since 2002 and more recently in pure nicotine products, and it has been suggested that, faced with declining cigarette markets in Europe and elsewhere, TTCs are preparing for a “post-cigarette era”. Since 2008, TTCs have been lobbying EU member states and the European Commission to remove the ban on snus sales, arguing that public health would be improved if governments allowed potentially reduced-harm products like snus onto the market. At the end of 2012, however, the European Commission proposed that the ban on snus sales should be continued. Here, to help inform this controversial policy debate, the researchers explore the interest of TTCs in SLT and pure nicotine in Europe from the 1970s to the present by examining internal tobacco documents and compare these interests with public claims of support for harm reduction made by TTCs.
What Did the Researchers Do and Find?
By searching the Legacy Tobacco Documents Library (internal tobacco industry documents released following US litigation cases), the researchers identified 416 documents that detail the historical interest of TTCs in SLT and pure nicotine and their efforts to enter European markets, and to influence national and EU public-health policy. The researchers analyzed these documents using a “hermeneutic” approach—methodical reading and re-reading of the documents to identify themes and sub-themes. Finally, they used TTC investor presentations and other documents to confirm these themes and to provide recent data on TTC investment in SLT. British American Tobacco (BAT) explored the opportunities for marketing SLT products in Europe from 1971 onwards. This exploration was driven by regulatory threats and health concerns, both of which were likely to impact tobacco sales, and by the potential to create a new form of tobacco use among people no longer interested in taking up smoking. TTCs did not begin to invest in SLT, however, until 2002, a time when EU cigarette sale volumes started to decline, smoke-free legislation was being introduced, and tobacco harm reduction first became a major public-health issue. All the TTCs have now invested in snus even though snus test markets appear to have failed and even though there is little evidence in corporate materials that snus is central to the business strategy of TTCs.
What Do These Findings Mean?
These findings suggest that BAT's early interest in SLT in Europe was driven by business concerns and was based on the potential for creating an alternative form of tobacco use among people—particularly young people—who would no longer take up smoking because of health concerns. They also suggest that TTC investments in snus were defensive—by buying up snus manufacturers and more recently nicotine producers, TTCs have eliminated competition between cigarettes and lower-risk products, thereby helping to maintain the current market balance in favor of cigarettes while ensuring the long-term future of TTCs should cigarette sales decline further. Although these findings are limited by the possibility that some relevant documents may have been omitted from this analysis, they nevertheless raise the concern that, if TTC investment in SLT continues, competition between cigarettes and SLT will reduce the potential for harm reduction to benefit public health. Legalization of snus sales in the European Union may therefore have considerably less benefit than envisaged.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001506.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about the Framework Convention on Tobacco Control, an international treaty for tobacco control; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
Details of European Union legislation on the manufacture, presentation, and sale of tobacco products is available (in several languages)
Wikipedia has pages on tobacco harm reduction and on snus (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Legacy Tobacco Documents Library is a searchable public database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and their tactics to influence tobacco regulation
doi:10.1371/journal.pmed.1001506
PMCID: PMC3769209  PMID: 24058299
21.  Gene patents and personalized medicine - what lies ahead? 
Genome Medicine  2009;1(9):92.
Gene patents have generally not impeded biomedical research, but some problems that arise in genetic diagnostics can be attributed to exclusively licensed gene patents. Gene patents for therapeutics have often been litigated but have received surprisingly little public outcry. In stark contrast, genetic diagnostics have been highly controversial but rarely litigated: no case has gone to trial and there is little case law to guide policy. Most recently the Secretary's Advisory Committee for Genetics Health and Society (SACGHS) released a draft report examining how patenting and licensing affect access to clinical genetic testing in the US. The SACGHS reported that patents neither greatly hindered nor facilitated patient access to genetic testing; both the harms and the benefits of patents on genetic diagnostics have been exaggerated. Problems do occur when patents are exclusively licensed to a single provider and no alternative is available. Courts have been changing the thresholds for what can be patented, and how strongly patents can be enforced. Technologies for sequencing, genotyping and gene expression profiling promise to guide clinical decisions in managing common chronic diseases and infectious diseases, and will likely be an integral part of personalized medicine. Developing such genomic tests may require mapping a complex intellectual property landscape and cutting through thickets of patented DNA sequences and related methods. Our preliminary studies have found patent claims that, if strictly enforced, might block the use of multi-gene tests or full-genome sequence data. Yet new technologies promise to reduce the costs of complete genomic sequencing to prices that are comparable to current genetic tests for a single condition. Courts, companies, and policy makers seem unlikely to allow intellectual property to obstruct such technological advance, but prudent policy will depend on careful analysis and foresight. The SACGHS report signals that the US government is paying attention, and increases the odds that policy will foster socially beneficial uses of genetic testing while preserving intellectual property incentives and mitigating the problems that arise from legal monopolies.
doi:10.1186/gm92
PMCID: PMC2768999  PMID: 19804612
22.  Tobacco Industry Manipulation of Tobacco Excise and Tobacco Advertising Policies in the Czech Republic: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2012;9(6):e1001248.
Risako Shirane and colleagues examined the the Legacy Tobacco Documents Library and found evidence of transnational tobacco company influence over tobacco advertising and excise policy in the Czech Republic, a country with one of the poorest tobacco control records in Europe.
Background
The Czech Republic has one of the poorest tobacco control records in Europe. This paper examines transnational tobacco companies' (TTCs') efforts to influence policy there, paying particular attention to excise policies, as high taxes are one of the most effective means of reducing tobacco consumption, and tax structures are an important aspect of TTC competitiveness.
Methods and Findings
TTC documents dating from 1989 to 2004/5 were retrieved from the Legacy Tobacco Documents Library website, analysed using a socio-historical approach, and triangulated with key informant interviews and secondary data. The documents demonstrate significant industry influence over tobacco control policy. Philip Morris (PM) ignored, overturned, and weakened various attempts to restrict tobacco advertising, promoting voluntary approaches as an alternative to binding legislation. PM and British American Tobacco (BAT) lobbied separately on tobacco tax structures, each seeking to implement the structure that benefitted its own brand portfolio over that of its competitors, and enjoying success in turn. On excise levels, the different companies took a far more collaborative approach, seeking to keep tobacco taxes low and specifically to prevent any large tax increases. Collective lobbying, using a variety of arguments, was successful in delaying the tax increases required via European Union accession. Contrary to industry arguments, data show that cigarettes became more affordable post-accession and that TTCs have taken advantage of low excise duties by raising prices. Interview data suggest that TTCs enjoy high-level political support and continue to actively attempt to influence policy.
Conclusion
There is clear evidence of past and ongoing TTC influence over tobacco advertising and excise policy. We conclude that this helps explain the country's weak tobacco control record. The findings suggest there is significant scope for tobacco tax increases in the Czech Republic and that large (rather than small, incremental) increases are most effective in reducing smoking.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to 10 million by 2030. Faced with this global tobacco epidemic, national and international bodies have drawn up conventions and directives designed to control tobacco. For example, European Union (EU) Directives on tobacco control call for member states to ban tobacco advertising, promotion, and sponsorship and to adopt taxation policies (for example, high levels of tobacco excise tax) aimed at reducing tobacco consumption. Within the EU, implementation of tobacco control policies varies widely but the Czech Republic, which was formed in 1993 when Czechoslovakia split following the 1989 collapse of communism, has a particularly poor record. The Czech Republic, which joined the EU in 2004, is the only EU Member State not to have ratified the World Health Organization's Framework Convention on Tobacco Control, which entered into force in 2005, and its tobacco control policies were the fourth least effective in Europe in 2010.
Why Was This Study Done?
During the communist era, state-run tobacco monopolies controlled the supply of cigarettes and other tobacco products in Czechoslovakia. Privatization of these monopolies began in 1991 and several transnational tobacco companies (TTCs)—in particular, Philip Morris and British American Tobacco—entered the tobacco market in what was to become the Czech Republic. In this socio-historical study, which aims to improve understanding of both effective tobacco excise policy and the ways in which TTCs seek to influence policy in emerging markets, the researchers analyze publically available internal TTC documents and interview key informants to examine efforts made by TTCs to influence tobacco advertising and tobacco excise tax policies in the Czech Republic. A socio-historical study examines the interactions between individuals and groups in a historical context.
What Did the Researchers Do and Find?
The researchers analyzed 511 documents (dated 1989 onwards) in the Legacy Tobacco Documents Library website (a collection of internal tobacco industry documents released through US litigation cases) that mentioned tobacco control policies in the Czech Republic. They also analyzed information obtained from sources such as tobacco industry journals and data obtained in 2010 in interviews with key Czech informants (including a tobacco industry representative and a politician). The researchers' analysis of the industry documents indicates that Philip Morris ignored, overturned, and weakened attempts to restrict tobacco advertising and promoted voluntary approaches as an alternative to binding legislation. Importantly, while the internal documents show that Philip Morris lobbied for a specific excise tax (a fixed amount of tax per cigarette, a tax structure that favors the expensive brands that Philip Morris mainly markets), the European strategy employed at that time by British American Tobacco was to lobby for a mixed excise structure that combined an “ad valorem” tax (a tax levied as a proportion of price) and a specific tax, an approach that favors a mixed portfolio of tobacco brands. By contrast, the documents show that TTCs collaborated in trying to keep tobacco taxes low and in trying to prevent any large tax increases. This collective lobbying successfully delayed the tobacco tax increases required as a condition of the Czech Republic's accession to the EU. Finally, the interview data suggest that TTCs had high-level political support in the Czech Republic and continue actively to attempt to influence policy.
What Do These Findings Mean?
These findings provide clear evidence that Philip Morris and British American Tobacco (the two TTCs that have dominated the Czech market since privatization of the tobacco industry) have significantly influenced tobacco advertising and excise policy in the Czech Republic since 1989. The findings, which also suggest that this influence is ongoing, help to explain the Czech Republic's poor tobacco control record, which was reflected in a fall in the real price of cigarettes between 1990 and 2000. More generally, this study provides valuable insight into how TTCs might try to influence policy in other emerging markets. Improvements in global tobacco control, the researchers conclude, will be possible only if efforts are made to protect tobacco control policies from the vested interests of the tobacco industry, a principle enshrined in the WHO Framework Convention on Tobacco control, and if public and political attitudes to the industry shift.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001248.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about its Framework Convention on Tobacco Control
For information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
The Framework Convention Alliance more information about the FCTC
Details of European Union legislation on excise duty applied to manufactured tobacco and on the manufacture, presentation and sale of tobacco products are available (in several languages)
The Legacy Tobacco Documents Library is a searchable public database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking and not start again
doi:10.1371/journal.pmed.1001248
PMCID: PMC3383744  PMID: 22745606
23.  Barriers to Provider-Initiated Testing and Counselling for Children in a High HIV Prevalence Setting: A Mixed Methods Study 
PLoS Medicine  2014;11(5):e1001649.
Rashida Ferrand and colleagues combine quantitative and qualitative methods to investigate HIV prevalence among older children receiving primary care in Harare, Zimbabwe, and reasons why providers did not pursue testing.
Please see later in the article for the Editors' Summary
Background
There is a substantial burden of HIV infection among older children in sub-Saharan Africa, the majority of whom are diagnosed after presentation with advanced disease. We investigated the provision and uptake of provider-initiated HIV testing and counselling (PITC) among children in primary health care facilities, and explored health care worker (HCW) perspectives on providing HIV testing to children.
Methods and Findings
Children aged 6 to 15 y attending six primary care clinics in Harare, Zimbabwe, were offered PITC, with guardian consent and child assent. The reasons why testing did not occur in eligible children were recorded, and factors associated with HCWs offering and children/guardians refusing HIV testing were investigated using multivariable logistic regression. Semi-structured interviews were conducted with clinic nurses and counsellors to explore these factors. Among 2,831 eligible children, 2,151 (76%) were offered PITC, of whom 1,534 (54.2%) consented to HIV testing. The main reasons HCWs gave for not offering PITC were the perceived unsuitability of the accompanying guardian to provide consent for HIV testing on behalf of the child and lack of availability of staff or HIV testing kits. Children who were asymptomatic, older, or attending with a male or a younger guardian had significantly lower odds of being offered HIV testing. Male guardians were less likely to consent to their child being tested. 82 (5.3%) children tested HIV-positive, with 95% linking to care. Of the 940 guardians who tested with the child, 186 (19.8%) were HIV-positive.
Conclusions
The HIV prevalence among children tested was high, highlighting the need for PITC. For PITC to be successfully implemented, clear legislation about consent and guardianship needs to be developed, and structural issues addressed. HCWs require training on counselling children and guardians, particularly male guardians, who are less likely to engage with health care services. Increased awareness of the risk of HIV infection in asymptomatic older children is needed.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Over 3 million children globally are estimated to be living with HIV (the virus that causes AIDS). While HIV infection is most commonly spread through unprotected sex with an infected person, most HIV infections among children are the result of mother-to-child HIV transmission during pregnancy, delivery, or breastfeeding. Mother-to-child transmission can be prevented by administering antiretroviral therapy to mothers with HIV during pregnancy, delivery, and breast feeding, and to their newborn babies. According to a report by the Joint United Nations Programme on HIV/AIDS published in 2012, 92% of pregnant women with HIV were living in sub-Saharan Africa and just under 60% were receiving antiretroviral therapy. Consequently, sub-Saharan Africa is the region where most children infected with HIV live.
Why Was This Study Done?
If an opportunity to prevent mother-to-child transmission around the time of birth is missed, diagnosis of HIV infection in a child or adolescent is likely to depend on HIV testing in health care facilities. Health care provider–initiated HIV testing and counselling (PITC) for children is important in areas where HIV infection is common because earlier diagnosis allows children to benefit from care that can prevent the development of advanced HIV disease. Even if a child or adolescent appears to be in good health, access to care and antiretroviral therapy provides a health benefit to the individual over the long term. The administration of HIV testing (and counselling) to children relies not only on health care workers (HCWs) offering HIV testing but also on parents or guardians consenting for a child to be tested. However, more than 30% of children in countries with severe HIV epidemics are AIDS orphans, and economic conditions in these countries cause many adults to migrate for work, leaving children under the care of extended families. This study aimed to investigate the reasons for acceptance and rejection of PITC in primary health care settings in Harare, Zimbabwe. By exploring HCW perspectives on providing HIV testing to children and adolescents, the study also sought to gain insight into factors that could be hindering implementation of testing procedures.
What Did the Researchers Do and Find?
The researchers identified all children aged 6 to 15 years old at six primary care clinics in Harare, who were offered HIV testing as part of routine care between 22 January and 31 May 2013. Study fieldworkers collected data on numbers of child attendances, numbers offered testing, numbers who underwent HIV testing, and reasons why HIV testing did not occur. During the study 2,831 children attending the health clinics were eligible for PITC, and just over half (1,534, 54.2%) underwent HIV testing. Eighty-two children tested HIV-positive, and nearly all of them received counselling, medication, and follow-up care. HCWs offered the test to around 75% of those eligible. The most frequent explanation given by HCWs for a diagnostic test not being offered was that the child was accompanied by a guardian not appropriate for providing consent (401 occasions, 59%); Other reasons given were a lack of available counsellors or test kits and counsellors refusing to conduct the test. The likelihood of being offered the test was lower for children not exhibiting symptoms (such as persistent skin problems), older children, or those attending with a male or a younger guardian. In addition, over 100 guardians or parents provided consent but left before the child could be tested.
The researchers also conducted semi-structured interviews with 12 clinic nurses and counsellors (two from each clinic) to explore challenges to implementation of PITC. The researchers recorded the factors associated with testing not taking place, either when offered to eligible children or when HCWs declined to offer the test. The interviewees identified the frequent absence or unavailability of parents or legal guardians as an obstacle, and showed uncertainty or misconceptions around whether testing of the guardian was mandatory (versus recommended) and whether specifically a parent (if one was living) must provide consent. The interviews also revealed HCW concerns about the availability of adequate counselling and child services, and fears that a child might experience maltreatment if he or she tested positive. HCWs also noted long waiting times and test kits being out of stock as practical hindrances to testing.
What Do These Findings Mean?
Prevalence of HIV was high among the children tested, validating the need for PITC in sub-Saharan health care settings. Although 76% of eligible attendees were offered testing, the authors note that this is likely higher than in routine settings because the researchers were actively recording reasons for not offering testing and counselling, which may have encouraged heath care staff to offer PITC more often than usual. The researchers outline strategies that may improve PITC rates and testing acceptance for Zimbabwe and other sub-Saharan settings. These strategies include developing clear laws and guidance concerning guardianship and proxy consent when testing older children for HIV, training HCWs around these policies, strengthening legislation to address discrimination, and increasing public awareness about HIV infection in older children.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001649.
This study is further discussed in a PLOS Medicine Perspective by Davies and Kalk
The Joint United Nations Programme on HIV/AIDS publishes an annual report on the global AIDS epidemic, which provides information on progress towards eliminating new HIV infections
The World Health Organization has more information on mother-to-child transmission of HIV
The World Health Organization's website also has information about treatment for children living with HIV
Personal stories about living with HIV/AIDS, including stories from young people infected with HIV, are available through Avert, through NAM/aidsmap, and through the charity website Healthtalkonline
doi:10.1371/journal.pmed.1001649
PMCID: PMC4035250  PMID: 24866209
24.  Medical Evidence of Human Rights Violations against Non-Arabic-Speaking Civilians in Darfur: A Cross-Sectional Study 
PLoS Medicine  2012;9(4):e1001198.
Alexander Tsai and colleagues review medical records from the Amel Centre, Sudan, to assess consistency between recorded medical evidence and patient reports of human rights violations by the Government of Sudan and Janjaweed forces.
Background
Ongoing conflict in the Darfur region of Sudan has resulted in a severe humanitarian crisis. We sought to characterize the nature and geographic scope of allegations of human rights violations perpetrated against civilians in Darfur and to evaluate their consistency with medical examinations documented in patients' medical records.
Methods and Findings
This was a retrospective review and analysis of medical records from all 325 patients seen for treatment from September 28, 2004, through December 31, 2006, at the Nyala-based Amel Centre for Treatment and Rehabilitation of Victims of Torture, the only dedicated local provider of free clinical and legal services to civilian victims of torture and other human rights violations in Darfur during this time period. Among 325 medical records identified and examined, 292 (89.8%) patients from 12 different non-Arabic-speaking tribes disclosed in the medical notes that they had been attacked by Government of Sudan (GoS) and/or Janjaweed forces. Attacks were reported in 23 different rural council areas throughout Darfur. Nearly all attacks (321 [98.8%]) were described as having occurred in the absence of active armed conflict between Janjaweed/GoS forces and rebel groups. The most common alleged abuses were beatings (161 [49.5%]), gunshot wounds (140 [43.1%]), destruction or theft of property (121 [37.2%]), involuntary detainment (97 [29.9%]), and being bound (64 [19.7%]). Approximately one-half (36 [49.3%]) of all women disclosed that they had been sexually assaulted, and one-half of sexual assaults were described as having occurred in close proximity to a camp for internally displaced persons. Among the 198 (60.9%) medical records that contained sufficient detail to enable the forensic medical reviewers to render an informed judgment, the signs and symptoms in all of the medical records were assessed to be consistent with, highly consistent with, or virtually diagnostic of the alleged abuses.
Conclusions
Allegations of widespread and sustained torture and other human rights violations by GoS and/or Janjaweed forces against non-Arabic-speaking civilians were corroborated by medical forensic review of medical records of patients seen at a local non-governmental provider of free clinical and legal services in Darfur. Limitations of this study were that patients seen in this clinic may not have been a representative sample of persons alleging abuse by Janjaweed/GoS forces, and that most delayed presenting for care. The quality of documentation was similar to that available in other conflict/post-conflict, resource-limited settings.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Conflict in the Darfur region of Sudan between Arabic- and non-Arabic-speaking tribes over the past decade has resulted in a severe humanitarian crisis. According to the United Nations, more than 2.7 million people have fled from their homes to camps for internally displaced persons (IDPs) or to refugee camps in neighboring Chad, and up to 300,000 people have died from war, hunger, and disease since the conflict started. The origins of this conflict go back many years, but in 2003, organized rebel forces began attacking government targets, accusing the Government of Sudan (GoS) of oppressing black Africans in favor of Arabs. In response, the GoS attacked the rebel forces, but some observers allege it also targeted non-Arabic-speaking civilians, in contravention of international laws of war. Observers have also accused the GoS of having links with the Janjaweed militias, nomadic Arabs who attack settled black farmers, although the GoS denies any such links. Indeed, reports of systematic, targeted assaults on non-Arabic-speaking civilians, of large-scale disruption of rural livelihoods, and of deliberate consignment to living conditions likely to cause death have prompted some observers to accuse the GoS of genocide (violent crimes committed against a national, ethnical, racial, or religious group with the intention of destroying that group) and the International Criminal Court to issue arrest warrants for the allegedly responsible authorities.
Why Was This Study Done?
Most investigations of claims of violence against civilians in Darfur have relied on self-reported data gathered from people living in refugee camps outside Sudan. Because these data could be biased, in this cross-sectional study (a study that characterizes a population at a single point in time), the researchers investigate the nature and geographic scope of alleged abuses against civilians in Darfur and endeavor to substantiate these allegations by analyzing the medical records of patients attending the Amel Centre for Treatment and Rehabilitation of Victims of Torture in Nyala, South Darfur. Opened in 2004, this center provided free clinical and legal services to civilians affected by human rights violations. Its staff fled in 2009 because of increasingly dangerous working conditions; the medical records used in this study were sent out of Sudan before the staff fled.
What Did the Researchers Do and Find?
Between September 28, 2004, and December 31, 2006, 325 patients were seen at the Amel Centre. According to their medical records, 292 patients from 12 different non-Arabic-speaking tribes alleged that they had been attacked by GoS or Janjaweed forces in rural areas across Darfur. Nearly all the patients reported that they had been attacked in the absence of active armed conflict between GoS/Janjaweed forces and rebel groups. Half of them claimed that they had been beaten, two-fifths reported gunshot wounds, a third reported destruction or theft of property, and nearly a third reported involuntary detainment. Half of the 73 women seen at the center disclosed that they had been sexually assaulted, often near IDP camps. Only 198 medical records contained sufficient detail to enable the researchers to determine whether the documented medical evidence was consistent with the alleged abuses. However, in all these cases, the researchers judged that the medical evidence was consistent with, highly consistent with, or virtually diagnostic of the alleged abuses.
What Do These Findings Mean?
These findings provide credible medical evidence that is consistent with torture and other human rights violations being inflicted on non-Arabic-speaking civilians in Darfur from 2004 to 2006. These findings cannot be used to estimate the population incidence of attacks on civilians or to corroborate claims of assailants' identities or of genocidal intent. Moreover, their accuracy may be affected by several limitations of this study. For example, during the study period, only patients who obtained a medical evidence form from the police were permitted to receive treatment from an authorized medical officer; obtaining such a form likely represented a considerable hurdle to accessing health care services. Nevertheless, the widespread, organized, and sustained pattern of attacks documented in this study is consistent with the possibility that the actions of Janjaweed and GoS forces during the conflict in Darfur may constitute war crimes, crimes against humanity, and/or acts of genocide. Importantly, these findings also highlight the need to provide adequate protection for health professionals working in countries affected by internal conflicts.
Additional Information
Please access these web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001198.
The African UnionUnited Nations Mission in Darfur (UNAMID) provides background information and up-to-date news about the ongoing conflict in Darfur Amnesty International, which campaigns for human rights, provides background information and news about the current situation in Darfur
The Save Dafur Coalition also provides detailed information about the situation in Darfur Physicians for Human Rights, a non-profit organization that mobilizes health professionals to advance health, dignity, and justice, is calling for security in Darfur and compensation and restitution for survivors of the conflict
Wikipedia has pages on Darfur and on genocide (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
Details on warrants of arrest issued by the International Criminal Court in response to the situation in Dafur are available
doi:10.1371/journal.pmed.1001198
PMCID: PMC3317898  PMID: 22509136
25.  Regulating compassion: an overview of Canada's federal medical cannabis policy and practice 
Background
In response to a number of court challenges brought forth by Canadian patients who demonstrated that they benefited from the use of medicinal cannabis but remained vulnerable to arrest and persecution as a result of its status as a controlled substance, in 1999 Canada became the second nation in the world to initiate a centralized medicinal cannabis program. Over its six years of existence, this controversial program has been found unconstitutional by a number of courts, and has faced criticism from the medical establishment, law enforcement, as well as the patient/participants themselves.
Methods
This critical policy analysis is an evidence-based review of court decisions, government records, relevant studies and Access to Information Act data related to the three main facets of Health Canada's medicinal cannabis policy – the Marihuana Medical Access Division (MMAD); the Canadians Institute of Health Research Medical Marijuana Research Program; and the federal cannabis production and distribution program. This analysis also examines Canada's network of unregulated community-based dispensaries.
Results
There is a growing body of evidence that Health Canada's program is not meeting the needs of the nation's medical cannabis patient community and that the policies of the Marihuana Medical Access Division may be significantly limiting the potential individual and public health benefits achievable though the therapeutic use of cannabis. Canada's community-based dispensaries supply medical cannabis to a far greater number of patients than the MMAD, but their work is currently unregulated by any level of government, leaving these organizations and their clients vulnerable to arrest and prosecution.
Conclusion
Any future success will depend on the government's ability to better assess and address the needs and legitimate concerns of end-users of this program, to promote and fund an expanded clinical research agenda, and to work in cooperation with community-based medical cannabis dispensaries in order to address the ongoing issue of safe and timely access to this herbal medicine.
doi:10.1186/1477-7517-5-5
PMCID: PMC2267789  PMID: 18226254

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