South Africa: TAC, COSATU and allies file complaint of excessive pricing

On 19 September 2002, the Treatment Action Campaign (TAC), the Council of South African Trade Unions (COSATU), the Chemical, Energy, Paper, Printing, Wood and Allied Workers' Union (CEPPWA), and eight individuals (health-care workers and people living with HIV/AIDS) launched a complaint with the country's Competition Commission against two major transnational pharmaceutical companies. TAC and its allies allege that GlaxoSmithKline (GSK) has engaged in excessive pricing for its antiretroviral drugs Retrovir (zidovudine or AZT), 3TC (lamivudine), and Combivir (AZT/lamivudine), and that Boeringer Ingelheim (BI) has engaged in excessive pricing of its antiretroviral drug Viramune (nevirapine).     

Canadian "medical necessity" and the right to health

In this article, Kathryn Garforth examines legal claims to health care in South Africa and Canada. Both countries face rising costs of health care that put a great strain on publicly funded systems, albeit in radically different contexts. Kathryn argues that despite these differences there are similarities in how litigants in South Africa and Canada have framed their claims to healthcare services, in how governments have responded, and in the factors courts have analyzed in reaching decisions. In South Africa, the leading case is Treatment Action Campaign (TAC) et al v Minister of Health et al, a constitutional challenge, while in Canada the relevant jurisprudence concerns the interpretation of the concept of medical necessity, articulated for the most part in non-constitutional cases.     

South Africa: Treatment Action Campaign steps up pressure

In December 2002, in its ongoing efforts to secure access to affordable HIV/AIDS treatment for all South Africans, the grassroots organization Treatment Action Campaign (TAC) initiated two new proceedings over governmental failure to act to prevent mother-to-child transmission of HIV. In March 2003, it launched a national civil disobedience campaign to pressure government into implementing a national treatment and prevention plan, including taking measures to ensure access to affordable medicines.     

For whom does prison-based drug treatment work? Results from a randomized experiment

Objectives

Prison-based therapeutic community (TC) drug treatment followed by community aftercare is widely recognized as the most effective treatment paradigm for drug-dependent offenders. However, few randomized experiments have addressed this question and fewer studies have examined how interactions between treatment modality and individual characteristics may explain variations in outcomes.

Methods

Using a randomized experimental design, this study examined the effects of treatment modality [TC vs. Outpatient (OP) group counseling], individual psychosocial characteristics (e.g., risk, negative affect), and interactions on reincarceration over a 3-year follow-up period. Survival analysis using Cox regression with covariates was used to analyze data obtained from 604 subjects at a specialized drug treatment prison.

Results

The expected advantage of TC failed to emerge. Critical and heretofore unexamined interactions between treatment modality (TC vs. OP), inmate levels of risk, and negative effect help explain these unexpected findings.

Conclusion

The superiority of prison TC to less intensive OP counseling was not supported. The effects of TC appear to be conditioned by critical responsivity factors that have received little empirical attention.     

Treatment Action Campaign (TAC) v South Africa (Minister of Health): reflections on the right to health care in Canada

In this article, Showkat Yazdanian examines the potential impact of the South African Constitutional court's decision in TAC v Minister of Health on the right to health care in Canada. Showkat first focuses on the potential utility of international treaties and precedents as a means to uphold the right to preventative health care in Canada. She then examines the Canadian Constitution's bearing on a right to health care, including an analysis of the current division of federal and provincial health powers.     

Patents for critical pharmaceuticals: the AZT case

Patents and other statutory types of market protections are used in the United States to promote scientific research and innovation. This incentive is especially important in research intensive fields such as the pharmaceutical industry. Unfortunately, these same protections often result in higher monopoly pricing once a successful product is brought to market. Usually this consequence is viewed as the necessary evil of an incentive system that encourages costly research and development by promising large rewards to the successful inventor. However, in the case of the AIDS drug Zidovudine (AZT), the high prices charged by the pharmaceutical company owning the drug have led to public outcry and a re-examination of government incentive systems. This Note traces the evolution of these incentive programs--the patent system, and, to a lesser extent, the orphan drug program--and details the conflicting interests involved in their development. It then demonstrates how the AZT problem brings the interest of providing inventors with incentives for risky innovative efforts into a sharp collision with the ultimate goal of such systems: ensuring that the public has access to the resulting products at a reasonable price. Finally, the Note describes how Congress and the courts have attempted to resolve these problems in the past, and how they might best try to solve the AZT problem in the near future.     

Application of Fordisc 3.0 to Explore Differences Among Crania of North American and South African Blacks and Whites,

Using discriminant function analysis, classification accuracies for ancestry and sex in white and black South Africans were compared using North American (FDB), African groups in Howells (HDB), and South African (SADB) databases in FORDISC 3.0. (FD3). Twenty‐four standard linear measures were collected from a total of 86 black and 101 white crania obtained from the Pretoria Bone Collection. White and black South Africans classified 73% correctly in FDB, 55% correctly in HDB, and 71% correctly in SADB. The percentage of atypical cases was higher with FDB than SADB. In all three databases, misclassification occurred more with sex than ancestry revealing differences in sexual dimorphism between population groups. Broad ancestral differences may explain low misclassification rates for ancestry. FD3, with a modern South African reference sample, can assist South African anthropologists to standardize methodology and to justify procedures for estimating ancestry.     

BioChem Pharma wins patent dispute over 3TC

In December 2000, the US Board of Patent Appeals and Interferences, a branch of the US Patent and Trademark Office (USPTO), upheld BioChem Pharma's claim to hold the patent on 3TC.     

Canadian Supreme Court upholds,but limits,AZT patent

On 5 December 2002, the Supreme Court of Canada ended a long-running dispute when it unanimously upheld the validity of the Canadian patent on the antiretroviral drug zidovudine (AZT) held by Glaxo Wellcome (now GlaxoSmithKline).     

Stability of plasma total cholesterol, triglycerides, and apolipoproteins B and A-I during the early postmortem period

The stability of plasma lipids and apolipoproteins during the early postmortem period was studied by taking four duplicate blood samples from eight cadavers 2, 6, 12, and 24 h after death. The bodies were kept at +4 degrees C. The plasma samples were analyzed for total cholesterol (TC), triglycerides (TG), apolipoprotein B (apo B), and apolipoprotein A-I (apo A-I). In TC, values rose by 6 and 11% in two cases, and in six cases diminished 3 to 15% during the first 6 h compared to values obtained 2 h postmortem. The greatest changes were a continuing rise in one case by 33% and a fall by 21% in another case during 24 h. In TG values marked changes took place including one case with a rise of 67% within 24 h. The concentrations of apo B rose by 9 to 11% in three cases and fell by 3 and 4% in two cases during 6 h, but during the whole study period a rise up to 78% occurred. In the concentrations of apo A-I, cases fell by as much as 42% in 6 h, and in one case rose by 20% during 6 h. The results indicate that unpredictable fluctuations occur in plasma lipid and apolipoprotein values within 24 h after death, and they should be interpreted cautiously if the samples have been taken after a prolonged postmortem period.     

Introducing eNoC – A simple,excel-based tool for improved assignment of the number of contributors (NoC) to a mixture

Assigning NoC in a mixed STR profile is an important preliminary step in computing a likelihood ratio (LR). A common metric is maximum allele count (MAC) whereby the locus exhibiting the largest number of alleles is used to set the NOC. This metric can be supplemented by considering total allele count (TAC) and locus allele count (LAC). TAC is the total number of alleles across all loci and is compared with probability distributions generated in silico. LAC works similarly, save that the probability distributions are generated at the locus level. Herein, we present a comparative analysis of these three metrics using a dataset of 10,000 of each of 2–7 person simulated ground truth mixtures. These datasets were used to generate parameter distributions for each NoC. This analysis showed LAC to be the most accurate single metric in all circumstances tested. We have developmentally validated an excel-based tool to automate calculations for use by operational caseworkers.     

Assessing zygomatic shape and size for estimating sex and ancestry in a South African sample

Unidentified, decomposed and skeletonised human remains are frequently found in South Africa, therefore, standardised, reliable and relevant sex and ancestry estimation methods are required for forensic identification. This study assessed sex and ancestral variation in zygomatic size and shape in a South African population using geometric morphometric analyses. The zygoma of 158 South African individuals were sampled. Eight zygomatic landmarks were captured in 3-dimensions using a Microscribe G2 digitiser and assessed using procrustean geometric morphometrics. Shape and size differences were analysed using multivariate linear regression, discriminant function and canonical variate analyses. Males had significantly larger zygomas than females. Significant shape variation was found between ancestral groups. Bantu-speaking and Mixed ancestry individuals had narrower, shorter and more anteriorly projecting orbital margins, whilst Europeans had vertically elongated and receded orbital margins. European ancestral groups were most discernible from Bantu-speakers and Mixed ancestral groups. Ancestry estimation accuracies improved when ancestry was aggregated with sex. Pairwise ancestry-linked comparisons in females were as follows; Bantu-speakers (76%) from Europeans (72%), Bantu-speakers (71%) from Mixed ancestry (59%) and European (72%) from Mixed ancestry (63%). Similarly, ancestry-linked comparisons in males were as follows; Bantu-speakers (77%) from Europeans (81%), Bantu-speakers (53%) from Mixed ancestry (59%) and European (72%) from Mixed ancestry (82%). Size differences are putatively linked to variations in hormone-regulated growth and muscular robusticity between males and females. Shape variations between ancestral groups are likely attributable to the heterogenous genetic and ancestral origins of the South African population. It is challenging to distinguish between South Africa Bantu speakers and Mixed ancestry people due to Mixed ancestry individuals having variable genetic contributions from Khoesan, Bantu-speakers, Europeans and Asians. Bantu-speaking and Mixed ancestry people had zygomatic morphologies consistent with historical thermoregulatory adaptations to sub-Saharan climates, reported in African-descendants. Zygomatic morphology in European descendants suggests ancestral origins from colder climatic regions. This study demonstrated the utility of the zygoma in distinguishing between ancestral groups in South Africa, but further research is required to develop population-specific standards to distinguish between South African populations with shared African ancestry. The zygoma shows a promising ability to estimate sex and ancestry in South Africans, suggesting population specific standards for this bone may be of forensic interest.     

Characteristic Features of Pediatric Firearm Fatalities—Comparisons Between Australia and the United States

Abstract:  Gunshot deaths in children less than 17 years of age from Adelaide, SA, Australia (1969–2005) and from San Diego County, CA, United States (1988–2005) were compared. Forty-two pediatric gunshot fatalities occurred in South Australia (1.1 cases/year; M:F = 30:12). There were 6 accidents (14%), 14 suicides (33%), and 22 homicides (52%). In San Diego there were 185 cases ( c. 10 cases/year; M:F = 148:37). There were 6 accidents (3%), 42 suicides (23%), 130 homicides (70%), and 7 undetermined cases (4%). The incidence of homicide was significantly higher in San Diego County compared to Adelaide ( p  < 0.001), with a higher proportion of murder–suicides occurring in Adelaide. There were markedly more accidents and suicides involving males in Adelaide and a far higher number of male homicide victims in San Diego County compared to females. Rifles of 0.22-caliber were preferred weapons in South Australia, compared to handguns in San Diego County.     

Use of "therapeutic complication" as a manner of death

Analyses of deaths due to therapeutic complications (TCs) provide important quality of care information for medical providers. In New York City, 463 deaths were investigated by the Office of Chief Medical Examiner and certified with TC as the manner of death in 2003. The TC manner of death is used for fatalities due to predictable complications of appropriate medical therapy. All death certificates and select autopsy, hospital, and investigation reports were reviewed. Data concerning cause of death, contributing conditions, age, race, and sex were extracted. The types of complications and the causes of death were classified into various types of surgical and nonsurgical categories of complications. These included: postoperative infections, pulmonary emboli, and technical and medication complications. The use of TC as a manner of death has benefits and limitations. Without the TC option, one is forced to certify certain deaths (e.g., penicillin anaphylaxis) either as natural or accident. The TC option allows easy identification and tracking of medical complications for public health purposes and also allows more consistent reporting of natural and medical-accidental deaths. In general, complications that occur during emergency surgeries/procedures for natural disease, tend to be certified with a natural manner. The "but for" test may be used to distinguish natural from TC deaths. There are criteria for distinguishing TC from accidents and homicides. TCs that occur during treatment of a potentially life-threatening injury, are superseded by the manner dictated by the circumstances of the initiating injury. The certification of TC usually does not address errors of omission, clinical judgement/management, or missed diagnoses.     

A survey of reported synthesis of methaqualone and some positional and structural isomers.

Methaqualone (2-methyl-3-o-tolyl-4(3H)-quinazolinone) is the illicit synthetic drug of choice amongst South African drug users. Historically police and forensic investigation has proven that all methaqualone seized by the South African Police Service originates from illicit manufacturing sites both inside, and outside South Africa's borders. From a drug enforcement, and forensic point of view it is, thus, of utmost importance that the various synthetic routes available to the illicit "chemist" are fully documented and understood. This is a prerequisite for effective illicit laboratory investigation, as well as chemical and precursor monitoring. This paper gives a brief introduction to the current status with regard to methaqualone use and production in South Africa, as well as an extensive review of the synthesis of methaqualone and selected isomers reported since 1946. A table summarizing synthetic routes reported in 32 reference sources is provided.     

Canadian court upholds Glaxo's patent on AZT

In October 2000, the Federal Court of Appeal issued the latest ruling in the ongoing dispute over the validity of Glaxo's Canadian patent for AZT, upholding Glaxo's patent but narrowing the scope of the claims it could validly make. The decision is now on appeal to the Supreme Court of Canada.     

The configuration of cervical spinous processes in black and white South African skeletal samples

The present study investigates the frequency of bifidity/nonbifidity in the black and white South African populations. Four-hundred skeletons of known race, sex, and tribal group were examined. Spinous processes were classified as bifid (bifurcate and cleft subtypes) and nonbifid (obtuse, pediculate, acinate, and clavate subtypes). Statistical analysis using the chi-squared probability test (p < 0.05) was carried out. Bifid spinous processes were present significantly more frequently in the white sample (58.9%) than in the black (31.6%). A bifid spinous process occurred most commonly in C2 (89%) followed by C5 (83%), C4 (79%), C3 (59.4%), and C6 (41.7%) in the white sample. A similar order of decrease in bifidity occurred in the black sample. C2 most commonly displayed the bifurcate subtype of spinous process, while the clavate subtype of nonbifid spinous process was the most common in both populations. The significantly higher frequency of bifidity in the white South African sample when compared to the black sample may suggest a population difference.     

Gender differences in effects of teen courts on delinquency: A theory-guided evaluation

Teen Court (TC) is an innovative juvenile diversion program that has spread rapidly across the United States in recent years. Despite its popularity, rigorous research on TC effectiveness is lacking. This study used data from a recent randomized trial of the effectiveness of TCs to examine gender differences and mediators anticipated by labeling theory. The study found gender differences in the effect of TC on delinquency. TC was found to increase delinquency for males and to have no effect for females. Implications related to the findings are discussed.     

Autosomal STR data on the enigmatic Andaman Islanders

We have analyzed nine autosomal STR loci (D3S1358, vWA, FGA, D8S1179, D21S11, D18S51, D5S818, D13S317, and D7S820) in 97 samples of enigmatic Andaman islanders including: 15 Great Andamanese, 46 Onge and 36 Nicobarese. Data was compared with the available data on Indian and South East Asian populations. Heterozygosity (H), power of discrimination (PD), probability exclusion (PE), typical paternity index (TPI), polymorphism information content (PIC), AMOVA and Arlequin analysis were carried out. Average heterozygosity observed was high and almost equal in all the populations. Similarly, PD, PE, TPI and PIC have been almost equal in all the populations.     

South Africa's unintended experiment in school choice: how the National Education Policy Act,the South Africa Schools Act and the Employment of Educators Act create the enabling conditions for quasi-markets in schools

School choice is often identified with right-leaning, voucher-happy, market-oriented public school systems like those found in the United States. Thus, the proposition that a social democratic state such as South Africa will offer many primary and secondary school learners far greater choice strikes many as counter-intuitive and implausible. The authors demonstrate that the three major pieces of education framework legislation—National Education Policy Act (NEPA), South Africa Schools Act (SASA) and Employment of Educators Act (EEA)—conspire with recent historical events and deep political and constitutional commitments to create South Africa's unintended experiment in school choice.

The authors emphasize that the legal framework created by legislation and regulation are necessary but not sufficient conditions—they prefer to call them enabling conditions—for the creation of quasi-markets in schools. The generation of quasi-markets in schools depends on several other factors required for all markets. The absence of many of these features in much of South Africa explains why the majority of South African learners do not have access to quasi-markets in schools. The absence of such features is largely a function of apartheid's legacy of deeply entrenched patterns of inequality in primary and secondary schooling.

Having demonstrated that historical, political, legal and economic conditions had the unintended consequence of producing school choice—and that school choice was not the result of the state's adoption of a conscious and deliberate policy—the authors examine the state's response to this de facto policy. The authors remain agnostic as to the desirability of the de facto policy and conclude with an exploration of some of the primary critiques of choice in South Africa. While they dismiss the ‘political’ critiques as largely facile, the available empirical evidence suggests the limited systemic benefits and the potentially deleterious consequences for the poorest of the poor who reside in areas where quasi-markets exist. The state's current ‘conscious’ attempts to re-engineer a modest mixed model, that emphasizes access to existing quasi-markets—and thus exploits superior existing school stock for the benefit of learners from historically disadvantaged communities—and that shifts public resources to those schools in the greatest need, accords with what little we know about the advantages and disadvantages of choice.