The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 3. Stool as a 'drug' or medicine.

The purpose of this article, the last in a series of three exploring the legal framework for the regulation of faecal microbiota transplantation (FMT) in South Africa (SA), is to determine the regulatory framework that applies to microbial-based treatments involving a level of manipulation that exceeds that of basic stool transplantation, e.g. processed FMT-derived products in capsule form. The article highlights the legal requirements for the registration of these products as biological medicines in SA law. Although human stool banks are not regulated in terms of the National Health Act 61 of 2003 (NHA) and regulations, the earlier articles point out that human stool fits the definition of human tissue and human biological material as defined by the NHA. For this reason, stool banks should be considered tissue banks in terms of the NHA and regulations. Healthcare practitioners and researchers involved in FMT banking and transplantation should strive to comply with these regulations in the absence of clear legal direction at present.

The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 2. Human stool as tissue?

Faecal microbiota transplantation (FMT) has been shown to be an effective treatment for recurrent Clostridioides difficile infection. The purpose of this article, the second of a series of three articles, is to explore the legal framework governing human FMT in South Africa (SA). FMT involves different modes of administration that require different regulatory considerations. The focus of this article is to explore the legal classification of human stool as tissue in terms of the National Health Act 61 of 2003, as well as the regulation of human stool banks as tissue banks. The article concludes with specific recommendations aimed at improving the current regulatory vacuum relating to the regulation of FMT in SA.

The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 1. A legal vacuum.

The legal regulation of faecal microbiota transplantation (FMT) in South Africa (SA) is currently unclear. The purpose of this article, the first of three in a series, is to explore the nature, role and clinical application of FMT in SA in order to determine, from a legal perspective, the appropriate regulatory pathways governing FMT as a procedure that may combine approaches for the treatment of drugs, human tissue for transplantation, or clinical treatment as part of the practice of medicine. FMT has been shown to be a novel, safe and effective treatment for recurrent Clostridioides difficile infection (CDI). Stool banks are instrumental in enabling access to FMT for patients and clinicians and help to catalyse research in the microbiome. However, the regulatory landscape in SA remains unclear. Microbial therapies such as FMT are necessary, especially in a time of rising microbiome-associated inflammatory diseases and increasing resistance to traditional antibiotics. FMT is now considered as part of the standard of care for recurrent CDI overseas, but is currently only being used for research purposes in a minority of clinical cases of CDI in SA. This article, which lays the foundation for consideration of this question in three parts, suggests that the relevant regulatory system would depend on the categorisation of human stool as tissue, the exact composition of the FMT, how it is administered to patients, and the relevant levels of manipulation of the stool for FMT-derived products.

Access to and utilisation of healthcare services by sex workers at truck-stop clinics in South Africa: A case study.

BACKGROUND: Sex worker-specific health services aim to respond to the challenges that this key population faces in accessing healthcare. These services aim to integrate primary healthcare (PHC) interventions, yet most services tend to focus on prevention of HIV and sexually transmitted infections (STIs). North Star Alliance (North Star) is a public-private partnership providing a healthcare service package in roadside wellness clinics (RWCs) to at-risk populations along transport corridors in sub-Saharan Africa. OBJECTIVES: To inform future service development for sex workers and describe North Star's contribution to healthcare provision to this population in South Africa, we describe services provided to and utilised by sex workers, and their views of these services. METHODS: Using a mixed-methods approach, we present quantitative analyses of anonymised North Star routine data for sex workers for October 2013 - September 2015, covering nine sites in seven provinces. Clinic visits were disaggregated by type of service accessed. We performed thematic analysis of 25 semi-structured interviews conducted at five clinics. RESULTS: A total of 2 794 sex workers accessed RWCs during the 2 years. Sex workers attending clinics were almost exclusively female (98.2%) and aged <40 years (83.8%). The majority were South African (83.8%), except at Musina, where the majority of clients were Zimbabwean. On average, sex workers visited the clinics 1.5 times per person. However, in most cases only one service was accessed per visit. PHC services other than for HIV and STIs were accessed more commonly than HIV-specific services and STI treatment. There was an increase in the number of services accessed over time, the figure almost doubling from 1 489 during the first year to 2 936 during the second year. Although during recruitment participants reported having had sex in exchange for goods or money during the past 3 months, not all participants self-identified as sex workers during interviews; however, all reported feeling at higher risk of poor health than the general population owing to their involvement in sex work. Participants reported satisfaction with site accessibility, location and operating hours. Sex workers accessing sites described services as being suitable and accessible, with friendly staff. CONCLUSIONS: RWCs were highly appreciated by the users, as they are suitable and accessible. The sex workers who used the clinics visited them irregularly, mostly for PHC services other than HIV and STIs. Services other than the one for which the sex worker came to the clinic rarely appeared to be offered. We recommend areas for service expansion.

Ownership and human tissue - the legal conundrum: A response to Jordaan's critique.

The debate over whether there should be a property or non-property approach with regard to human tissue is only the tip of the iceberg, because the issues involved are very complex, reflecting profound considerations on the nature of the self and the structuring of society; the balance of power between the citizen, the government and commercial interests; and human beings' perceptions of themselves and their bodies. This article responds to a publication by Donrich Jordaan titled 'Social justice and research using human biological material: A response to Mahomed, Nöthling-Slabbert and Pepper' in the July 2016 SAMJ. The original article to which Jordaan's critique refers and that provides the source for his response appeared in the South African Journal of Bioethics and Law in 2013, titled 'The legal position on the classification of human tissue in South Africa: Can tissues be owned?'. It is our contention that Jordaan's critique is based on a misinterpretation of the issues raised relating to the ownership of human tissue, an issue extensively debated in the academic sphere for many years. Jordaan's critique focuses on selected aspects of the original article and draws unjustifiable inferences from these. The purpose of this article is to contextualise Jordaan's critique and reaffirm the validity of the arguments made in the original article in 2013. There are, however, certain aspects of Jordaan's critique that we as authors of the original article acknowledge and appreciate in the spirit of academic discourse.

Large volume cryoprotectant-free vitrification: an alternative to conventional cryopreservation for human spermatozoa.

Vitrification is a simple and cost-effective method for the storage of human spermatozoa without the use of conventional cryoprotectants, by plunging the sperm suspension directly into liquid nitrogen. As a result, solidification of living cells without the formation of ice crystals is achieved during cooling. This study aimed to compare cryoprotectant-free vitrification to conventional cryopreservation protocols. Semen samples (n = 35) were collected from patients seeking diagnostic assistance at the Reproductive and Endocrine Unit at Steve Biko Academic Hospital. Samples were processed using a discontinuous density-gradient centrifugation method. Washed samples were split into two aliquots and cryopreserved either by means of cryoprotectant-free vitrification (sucrose + 1% albumin) or conventional slow freezing (TEST-yolk buffer). Post-thawing, the sperm motion parameters, mitochondrial membrane potential (Δψm) and DNA fragmentation were compared between the two groups. No significant differences were observed in the sperm motility parameters (P > 0.05). Significantly higher percentages of Δψm (11.99% ± 4.326% versus 6.58% ± 1.026%; P < 0.001) and lower percentages of DNA fragmentation (2.79% ± 1.017% versus 3.86% ± 1.38%; P < 0.01) were observed when comparing cryoprotectant-free vitrification to conventional cryopreservation. Cryoprotectant-free vitrification is a rapid and promising alternative to conventional methods resulting in good-quality spermatozoa post-thaw.

The Consumer Protection Act: no-fault liability of health care providers.

The introduction of no-fault or strict liability by the Consumer Protection Act 68 of 2008 (CPA) poses serious problems in the health care context. With a patient as a 'consumer' in terms of the CPA, health care practitioners may find themselves as 'suppliers' or 'retailers' as part of a supply chain, and potentially liable for harm and loss suffered by a patient in terms of the new no-fault liability provision. The claimant (patient) can sue anyone in the supply chain in terms of this provision, which places the health care practitioner who delivered the care in a very difficult position, as he or she is the most easily and often only identifiable person in the supply chain. Although the causal link between the harm suffered by the complainant will still need to be established on a balance of probabilities, the traditional common law obstacle requiring proof of negligence no longer applies. The article argues that this situation is unsatisfactory, as it places an increasingly onerous burden on certain health care practitioners.

Escalation in the relative prevalence of ciprofloxacin-resistant gonorrhoea among men with urethral discharge in two South African cities: association with HIV seropositivity.

OBJECTIVES: The objectives of this study were to assess the prevalence of ciprofloxacin-resistant gonorrhoea in two South African cities and to investigate the association between the isolation of ciprofloxacin-resistant Neisseria gonorrhoeae and the HIV serostatus of patients. METHODS: Gonococci were cultured from endourethral swabs taken from consecutive men with urethritis attending clinics in Johannesburg and Cape Town. Minimum inhibitory concentrations (MIC) for ciprofloxacin and ceftriaxone were determined with E-tests. Isolates with a ciprofloxacin MIC of 1 mg/l or greater were defined as resistant and isolates with a ceftriaxone MIC of 0.25 mg/l or less were defined as susceptible. Rapid tests were used to screen and confirm the presence of HIV antibodies. Survey data from 2004 were used as a baseline to assess trends in gonococcal resistance to ciprofloxacin. RESULTS: In 2004, the prevalence of ciprofloxacin resistance was 7% in Cape Town and 11% in Johannesburg. In 2007, 37/139 (27%) Cape Town isolates and 47/149 (32%) Johannesburg isolates were resistant to ciprofloxacin; in comparison with 2004 data, this represents 2.9-fold and 1.9-fold increases, respectively. All isolates were fully susceptible to ceftriaxone. There was a significant association between HIV seropositivity and the presence of ciprofloxacin-resistant gonorrhoea among patients (p = 0.034). CONCLUSIONS: Johannesburg and Cape Town have witnessed significant rises in the prevalence of ciprofloxacin-resistant gonorrhoea among men with urethritis. The resistant phenotype is linked to HIV seropositivity. There is now an urgent need to change national first-line therapy for presumptive gonococcal infections within South Africa.

National surveillance programme on susceptibility patterns of respiratory pathogens in South Africa: moxifloxacin compared with eight other antimicrobial agents.

AIMS: The susceptibility patterns of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Klebsiella pneumoniae, and Streptococcus pyogenes isolated from specimens submitted to 12 private laboratories in South Africa were determined. METHODS: Minimum inhibitory concentration (MIC) determinations were performed on the isolates in the microbiology laboratory at Tygerberg Hospital according to the recommendations of the National Committee for Clinical Laboratory Standards (NCCLS). RESULTS: According to the NCCLS breakpoints, 24% of 729 S pneumoniae isolates were sensitive, 30% intermediate, and 46% resistant to penicillin. Rates of macrolide resistance were high, with 61% of the pneumococci being resistant to clarithromycin and azithromycin. Co-trimoxazole resistance was also high, with 28% of pneumococcal strains being sensitive, 21% intermediate, and 51% resistant. beta Lactamase was produced by 7% of 736 H influenzae isolates and 91% of 256 M catarrhalis isolates. The quinolones, moxifloxacin and levofloxacin, were universally active against all isolates tested, which included S pneumoniae, H influenzae, M catarrhalis, K pneumoniae, and S pyogenes. CONCLUSIONS: Haemophilus influenzae and S pneumoniae were the most commonly isolated organisms. Resistance to penicillin was one of the highest reported in the world (76%) in S pneumoniae, as was macrolide resistance in pneumonocci, although surprisingly, only 14% of S pyogenes were resistant. The quinolones, moxifloxacin and levofloxacin, were active against all organisms tested, including the penicillin and macrolide resistant strains and moxifloxacin was more active than levofloxacin against pneumococci.

Glycosylated haemoglobin, blood glucose and serum cholesterol levels in diabetics treated with guar gum.

The diet of 10 insulin-dependent diabetics was modified for 3 months by the addition of guar gum to buttermilk rusks. Control of glycaemia was assessed by serial determination of total glycosylated haemoglobin A1. The effect of guar on serum cholesterol levels was noted. Guar gum supplementation failed to improve the long-term diabetic control, but significantly reduced serum cholesterol levels (P less than 0,01). The effect of guar on lipoprotein levels should be investigated more fully.