SA health regulator gives Ivermectin the red light … again! – Professor Aldous and Dr Mdladla interrogate

Professor Colleen Aldous and Dr Nathi Mdladla put pen to paper on a topic that is turning heads within the medical fraternity, Ivermectin. The piece below dives into the decision by the South African National Emergency Medicines List Committee (NEMCL) to continue disregarding ivermectin as a treatment for Covid-19 despite the lion’s share of evidence pointing towards the drug’s effectiveness. Aldous and Mdladla lambast the seven reasons listed by the health regulator, stating that science has been compromised by politics, vested interests and hidden agendas. The evidence is overwhelming, ivermectin does help and at worst – it causes no harm.  The cracks are starting to appear in the arguments of the WHO and related organisations, where science is clearly behind vested interests in terms of rank and importance. ‘Medicine has a tradition of doing what the prof says you must do, and where people fall out of line, they quickly get bullied back in.’ – Justin Rowe-Roberts

Two Profs Question NEMCL’S Red Light for Ivermectin

At a meeting hosted by the National Department of Health, the South African National Emergency Medicines List Committee (NEMCL) gave their reasons for continuing to give Ivermectin the red light. They persisted in rejecting the counterargument made by many world-renowned doctors and scientists – (including Nobel Laureate Satoshi Omura and other luminaries, to name a few, a Harvard professor and former NIH scientist with 30 years of clinical experience, Professor George Fareed, Yale’s Professor Harvey Risch, Professor Thomas Borody and of course Dr Paul Marik – second most published critical-care physician in the world) that Ivermectin should be made readily available because it is safe, with a safety profile on a par with aspirin, so at best it will save lives. At worst, it will do no harm. It is cheap, and there is already a body of evidence with strong signals that it reduces mortality and morbidity. The link to Professor George Fareed’s testimony on Ivermectin at a senate hearing in November 2020.

They are digging their heels in with a Type 2 error decision; not to permit the use of ivermectin other than in clinical trials because they feel that all current evidence is dismissible as insufficient in quantity and quality until a large double-blinded, randomised control trial (DBRCT) provides proof that Ivermectin reduces mortality and morbidity.

The NEMLC provides seven points as a rationale for their stance. See their slide below.

They argue that an Ivermectin intervention will result in vaccine hesitancy. This statement is anecdotal at best. In a search for “Ivermectin and vaccine hesitancy” in academic databases, we found no published data on vaccine hesitancy pertaining to treatment interventions. Vaccine hesitancy is multifaceted. The most important reasons for this, according to Saied et al. 1 are concerns regarding adverse events, its potential ineffectiveness against emerging strains, its perceived lack of testing, questions around its long-term safety and fear of contracting Covid-19 from the vaccine itself. Pfizer has already made the statement in a tweet that “Along with vaccines, success against Covid-19 will likely require antiviral treatments for those who contract the virus.” They have started their Phase 2/3 trials of PF-07321332, and MSD is currently busy with Phase 3 trials of molnupiravir, their antiviral. There is hope that these drugs will be released by the end of the year.

Dr Antony Fauci recently stated the importance of delivering a 7-10 day course of antivirals to cure the patients before the cytokine storm phase of the disease. Why can we not use Ivermectin, with its already established safety and efficacy in the meantime? And will these novel drugs be seen as causing vaccine hesitancy?

The NEMLC is also concerned that people may delay going to a doctor for treatment of Covid-19 while waiting for Ivermectin to work. This point is moot if a patient receives Ivermectin under the care of a doctor. They have already presented and will be monitored by their doctor. Those who are not anti-Ivermectin have never condoned unsupervised use.

They claim a societal loss of faith in professional integrity. This is happening on a large scale anyway, not because of Ivermectin. “Science” has become compromised by politics and vested interest. The mainstream authority meted out through medical orthodoxy has polarised society. The wilful dismissiveness and failure to engage with others outside of the ivory tower of regulatory medicine have alienated those who can read and understand science and contribute to the debate. We have personally tried to engage with people on the NEMLC and others who have published their views in the media. Rather than debating the scientific facts, we have been rejected.

Medicine has a tradition of doing what the prof says you must do, and where people fall out of line, they quickly get bullied back in. The NEMLC echoes the WHO; the NDOH makes sure its structures follow the NEMLC. Even some doctors in private practice, who are risk-averse, are made to tow the authoritarian line.

The threat of legal impact in South Africa is also moot. A court order has made ivermectin legal for use off-label, and SAHPRAs Controlled Compassionate Use Programme is still in place.

Reducing the ability to detect spin is risible. Last week a large media house flighted a short six-month-old video (for two days), which was loaded with misinformation about Ivermectin. It was mischievously entitled “Pet Parasite Drug Ivermectin touted as Covid-19 treatment”. Not only have science and perceptions around Ivermectin been advanced since the video was made in January, but the title perpetuates the incorrect assumption that ivermectin is an animal drug. This has been used as an argument by many opposing the use of Ivermectin in Covid-19 and is very misleading. In the same vein the NEMCL’s donkey graphic, above, also perpetuates this myth.

In the video, Dr Dale Bratzler incorrectly states that “most people will get better with either salt tablets or Ivermectin”, implying that Ivermectin has no advantage over a placebo. This is untrue given the trials that had been published up to January. He further states (that by January 2021) only lab studies had been concluded, which is incorrect, and since then, has become more inaccurate. He continues to state misleadingly that there are serious adverse effects such as liver failure.

Ivermectin has been used successfully for over four decades to treat onchocerciasis (river blindness) and other parasitic diseases. VigiAccess is the WHOs database of all adverse drug events and is available online (VigiAccess.org). According to VigiAccess, there are 5621 (10 August 2021) adverse events recorded since 1992, after over 4 billion human doses. Compare this with Remdesivir and Tocilizimab standard drug regimens given to most hospitalised Covid-19 patients in South Africa. Since 2019 Remdesivir has had 7073 adverse reactions, and since 2005 Tocilizumab has had 51334.

Which leads nicely to their next point. After starting the Ivermectin Interest Group with Dr Yakub Essack in December, I have realised just how research literate so many of our frontline doctors are. My bibliography of published research gets shared widely every time it’s updated. The public can rest assured that the doctors who use Ivermectin in their regimens are looking past the “insufficient evidence” rhetoric, doing their own reading of academic publications and are putting the lives of their patients first.

Informed consent is a requirement of SAHPRAs Controlled Compassionate Use Program. It is provided for on p 9 of their Section 21 application form, which can be found on their website. An informed consent document is not mandatory for the off-label use of ivermectin, but many doctors have used it. All doctors who follow good clinical practice will at the very least discuss the medications with their patients.

There is a glaring lack of science in the NEMLCs seven-point rationale to prevent the use of Ivermectin outside of a clinical trial. Are they science denialists? They have also completely ignored the scientific evidence and views of leading scientists and doctors who believe that Ivermectin complements the vaccine rollout. It can reduce sickness and hospital admissions and that lives can be saved NOW; before we have herd immunity, before we have emergency use for the novel drugs in the pipeline, and before any large DBRCT results for Ivermectin are published. The question is, are they genuinely acting in the interests of the sick patient?

1 Saied SM, Saied EM, Kabbash IA, Abdo SA. Vaccine hesitancy: Beliefs and barriers associated with COVID‐19 vaccination among Egyptian medical students. Journal of medical virology. 2021 Jul;93(7):4280-91.

  • Prof Colleen Aldous has a doctorate and is a full Professor and Health Care Scientist at UKZN’s medical school where she runs the doctoral academy at the College of Health Sciences. She has published over 130 peer-reviewed articles in rated journals.
  • Dr Nathi Mdladla is an Associate Professor and Head of Department of Intensive Care Medicine at the Dr George Mukhari Academic Hospital and Sefako Makgatho University. He currently manages the only Academic ICU treating COVID-19 with Ivermectin in South Africa. He is also a Cardiac Anaesthetist in private practice and the Co-Founder of the Southern African Society of Cardiothoracic Anaesthesiologists and currently its Deputy President.

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