By Anthony Rees – National Chairman (TNHA)
Despite the default skepticism of natural health product detractors, regulatory technocrats, and lazy media reporters, local statistics conclusively demonstrate that the majority of commercial natural health products are likely among the safest substances regularly consumed by tens of millions of South Africans.
A growing number of every-day South Africans are asserting their rights to choose and prioritize natural approaches for maintaining their health and wellness, witnessed by the expansion of brick and mortar health shops, online health stores, direct selling companies and informal markets where a growing variety of natural health products are traded. In this context, it has become crucial to provide research-backed information that is both accessible and reliable, empowering them to make informed choices aligned with their preferences.
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The utilization of over-the-counter natural health products, such as micro-nutrient supplements, herbal products, sports supplements, aromatherapy oils and homeopathic products, constitute an integral aspect of the daily regimen for a substantial segment of the South African population. As indicated by the World Health Organization, indigenous African Traditional Medicines are still embraced by a significant 60 – 80% of black South Africans. Findings from a 2017 national consumer survey reveal that 46% of South Africans regularly incorporate and consume supplements and other natural health products on a daily basis, or regularly according to their individual health needs. If each person in the 46% who use supplements alone (excluding African Traditional Medicines) take their supplements daily, the cumulative national intake would would be just over 10 billion individual doses per year.
Despite the ongoing and somewhat unfounded criticism of natural healthcare in the mainstream media and by certain quarters within the South African Health Products Regulatory Authority (“SAHPRA”), it is essential to acknowledge that both micro-nutrient supplements and and other forms of commercial natural health products fall within the ‘supersafe’ [or deminimus risk] classification of individual risk. This classification signifies that the risk of mortality resulting from their consumption is less than 1 in 10 million or more.
NO RECORDED DEATHS FROM COMMERCIAL NATURAL HEALTH PRODUCTS OVER THE LAST 12 YEARS.
SAHPRA, along with its predecessor, the Medicines Control Council, has maintained a comprehensive pharmacovigilance program for several decades. In 2011, the program was extended to encompass complementary medicines and health supplements, a development reflected in the official adverse drug reporting forms used by medical practitioners and pharmacists. Subsequently, this initiative was further expanded to include a smartphone application, enabling patients and consumers to submit unverified reports, which are then subject to follow-up procedures.
In the legal case of Alliance for Natural Health vs. Minister of Health and SAHPRA, adjudicated in the Gauteng High Court, it was established that SAHPRA’s vigilance database has, since its inception, yielded no documented instances of verifiable deaths relating to complementary medicines and health supplements.
Our Ministry of Health and SAHPRA rationalize their continued attempts to implement increasingly intricate, stringent and costly rent-seeking regulations which will severely impact public access to natural health products, citing rhetorical reasons of ‘public safety’ as a red herring. Because the public at large do not ready have access to the facts surrounding this assertion, this narrative gets some purchase, even though it is based on a false premise. A critical examination of the evidence reveals a lack of substantial support for such claims – the absence of tangible adverse outcomes begs the question: Where are the dead bodies?
The presented data provides insights into the relative likelihood of mortality associated with various daily activities and high risk diseases (often related to poor lifestyle management) in South Africa, against demonstrable harms associated with commercial natural health products. These figures offer a valuable perspective on the actual risk of death related to activities and causative factors leading to morbidity locally.
Drawing from combined decades of expertise in the natural health industry, the TNHA and its global alliance partners possesses in-depth knowledge of the safety and efficacy of supplements and natural remedies. If our Ministry of Health and SAHPRA genuinely prioritize public safety, they would actively promote the benefits of natural healthcare while addressing the questionable aspects of mainstream orthodox medicine. This includes addressing the over-reliance on inadequately tested, unnecessary, and potentially hazardous pharmaceutical medications that are excessively prescribed to individuals over the age of 50 who are at risk of chronic diseases.
Astoundingly, annually, more than 3,700 individuals succumb to severe adverse drug reactions arising from appropriately prescribed pharmaceutical medications that have received the endorsement of the South African Health Products Regulatory Authority (SAHPRA). To provide a meaningful context, this loss of life equates to the tragedy of 21 entire Boeing 737 aircraft, each accommodating 181 passengers, or 316 full minibus taxis, each carrying 12 passengers crashing and all occupants dying. Therefore risk of death from swallowing pharmaceutical drugs in South Africa is 3,700 times that of swallowing commercial natural health products.
Sadly, adverse drug reporting in South Africa remains woefully inadequate and incomplete. The 3,700 reports captured only represent a fraction of those that occur and are not reported. For instance, Matlala et al journal article, showed that adverse drug reaction reports to SAHPRA in 2017 (actually before the Authority came into effect, so to the MCC) had a mean completeness score of only 0.456 (s.d. = 0.221). Only 11.3% of reports had a completeness score of 0.8. Importantly, the completeness of reports submitted by consumers was comparable to those submitted by healthcare professionals. With such low reporting, the 3,700 deaths from Adverse Drug Reactions recorded per year is a very conservative estimate.
Adverse drug reactions (ADRs) are a significant cause of death in South Africa, particularly among patients admitted to adult medical wards. However, data on ADR patterns and the most common causative medicines are limited, especially outside of HIV and tuberculosis treatment programmes. A comprehensive survey conducted in 2015 across four public hospitals over a span of 30 days revealed some alarming statistics. The study found that adverse drug reactions (ADRs) played a significant role in the mortality rate among medical admissions. Out of 357 recorded deaths, 56 were found to be directly linked to adverse drug reactions, accounting for 2.9% of admissions.
Preventable medical injuries in South African hospitals are in the ‘Dangerous’ category, with a risk of permanent injury or death greater than 1 in 1,000. Medico-legal claims – claims based on medical negligence or malpractice – have skyrocketed in South Africa over the last two decades. In September this year, Select Committee on Appropriations was briefed by both the Department of Health (DoH) and the Auditor-General of South Africa (AG/AGSA) on the state of medico-legal claims across the provincial health departments. During its presentation, the Auditor-General informed Members of Parliament that the government had 15,148 claims made against the Department of Health during the 2021-2022 Financial Year and stood at at R125.3 billion (US $6.5 billion).
Wake Up Government!
SAHPRA should prioritize its core mandate given to it by our lawmakers, which involves the rigorous and prudent regulation of conventional pharmaceutical drugs, vaccines, and other biological medications. As evident from their internal data presented above, it is imperative that the organization undertakes necessary internal improvements before extending its regulatory oversight to benign natural health products. This expansion would involve their inclusion within the existing pharmaceutical licensing framework, which currently exhibits an excessive and unwarranted bureaucratic complexity.
Call to action
Please spread this information far and wide! Share it with your Member of Parliament, on Facebook, Twitter [X], Instagram and other social media, and email them to all your contacts. The more who people know the truth, the more difficult it will be for detractors of natural medicine to claim that it is a danger to the public and in need of further regulation or banning.
Take responsibility for your own health, keep yourself healthy and avoid the need to go to hospital!