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An image of the SARS-CoV-2 virus. Experts argue that efforts to pressure the South African Health Products Regulatory Authority to approve ivermectin as a means of fighting the virus are “extraordinary and dangerous.” (Image: Gerd Altmann from Pixabay)
A court case initiated by Afriforum runs the risk of undermining the scientific governance of medicine.
First published in Ground.
The obsessive pressure on the South African Healthcare Regulatory Authority (SAHPRA) to approve ivermectin is extraordinary and dangerous.
There are circumstances in which early, or even illegal, access to drugs is justified. In the early 2000s, I worked with the TAC to import fluconazole, a life-saving antifungal drug that had an obscene price tag in the country. A decade ago we advocated for access to prior approval of a TB drug called bedaquiline. I’ve written a lot on the subject, including a peer-reviewed article: Anything to stay alive: the challenges of a campaign for an experimental drug.
So you might think that you would sympathize with the push for ivermectin to treat Covid-19.
On the contrary. This is a dubious campaign that is undermining the scientific governance of medicine. Our fluconazole and bedaquiline campaigns were well researched and considered, and we tried to cooperate with the regulatory authority. This is in stark contrast to ivermectin.
Afriforum has launched a court offer for SAHPRA to overturn its decision that there is insufficient evidence to approve ivermectin for Covid-19. It is strange that a court, without experience in pharmaceutical science, is asked to reverse a thoughtful decision of the state institution with the experience and authority to make such decisions.
There is promising evidence that ivermectin is helpful for the treatment of Covid-19. But that evidence falls short of what is required to approve a drug. There is a system with clear standards for drug approval. As with all systems, there are extreme cases (eg bedaquiline at the time the MAH lobbied for access to prior approval). But ivermectin is not such an extreme case.
Ivermectin can work. But maybe not. Asking for it to be available before a properly conducted clinical trial has proven its efficacy against Covid-19 is like asking for a vaccine to be deployed before it has been tested. (It is interesting and concerning, by the way, that many of those promoting ivermectin are against vaccination.)
The drug approval system, which can be called the Scientific Governance of Medicine, exists for very good reasons. Most people will need to take medicine at some point in their lives. But very few people have the experience to determine whether a drug is safe or effective. They have to rely on their doctors to make decisions that are in their best interest, and not necessarily in the best interest of drug manufacturers, who have an incentive to market and sell drugs.
The ongoing thalidomide, Vioxx and opioid scandals, which have caused so many deformities and deaths, show why we need a well-defined and implemented system to regulate drugs. These scandals were somehow caused by regulatory failures. But properly acting regulatory bodies have prevented numerous unsafe or ineffective drugs from reaching the market.
The key to getting a drug approved is a large randomized clinical trial in which participants are divided into at least two groups: one that receives the drug and one that receives something else, usually a placebo.
We can’t decide that a drug should become standard practice just because a famous sports doctor says so on Twitter, no matter how smart he and his army of fans think he is. The only way to determine the safety and efficacy of a drug is to test it in well-conducted trials. We can’t guess. It is not a matter of opinion.
A tale of two drugs
Colchicine is an anti-inflammatory drug. Scientists from the Montreal Heart Institute (MHI) decided to test whether this drug could be useful against Covid-19. Some patients’ immune systems ramp up when they become infected, causing what is called a cytokine storm. This requires hospitalization and is often fatal. The theory was that colchicine could buffer the cytokine storm.
This week the MHI published the results of your study (not yet peer reviewed). Assuming the researchers made no mistakes, this study exemplifies high-quality medical research.
Participants testing positive for Covid-19, who were over 40 years old and had at least one high-risk criterion, were randomly assigned to receive a placebo or to receive 0.5 mg of colchicine daily for 30 days (twice per day for the first three days). Of the 2,195 people assigned to the colchicine arm, five died and 93 were hospitalized. Nine died in the placebo arm and 123 were hospitalized. The difference between the two arms is small but statistically significant. Colchicine has a modest but proven benefit in treating Covid-19.
One unpleasant side effect of colchicine is diarrhea. Despite this, there were more serious adverse events in the placebo group (and more people withdrew from the study or were lost to follow-up in the placebo group).
After this trial, doctors with newly diagnosed Covid-19 patients who are at high risk of becoming ill know that they can give colchicine to a patient, what side effects to expect, what dose to prescribe, for how long, and how likely the patient will be. will benefit from the drug. The doctor and patient can decide together, based on clear and convincing data, whether the modest potential benefit outweighs the likely diarrhea.
It’s not a wonderful drug, they don’t exist yet for Covid-19, including ivermectin, but it’s readily available and cheap – R5 per tablet. The full one-month course currently costs R165.
A well-designed clinical trial is all that is needed.
There has been very little buzz on social media about colchicine, and maybe it’s better.
Compare this to ivermectin.
The results of several ivermectin clinical trials have been published, but all are incompletely described, poorly designed, or small – last week The Lancet published an ivermectin study with only 24 patients, 12 in each group!
Ivermectin advocates point to a analysis of ivermectin clinical trials led by Andrew Hill, an excellent scientist at the University of Liverpool. Hill has found that if the trial results are combined with ivermectin, the drug is associated with a 75% reduction in mortality. This is very promising.
But Hill concludes: “Many of the included studies were not peer-reviewed and meta-analyzes are prone to confusion. Ivermectin needs to be validated in larger, adequately controlled randomized trials before the results are sufficient for review by regulatory authorities. “
Also, there is no consensus yet on what dose of ivermectin to use, what form of ivermectin to use (intravenous, pill, or nasal spray), how long to use it, or in which patients to use it. (It’s also not clear why an antiparasitic drug might have benefits against a viral disease, although this is not a barrier to approval.)
The price is also unclear, but it is definitely not a cheap drug. A quote I saw for a four tablet pack to be imported was R3,201.75 without VAT. A 50 ml injectable solution for sheep and cattle available in the country costs R899.
SAHPRA issued a sensible statement this week concluding that the benefits and risks of ivermectin remain uncertain. SAHPRA quotes the Covid-19 subcommittee of the National Committee for Essential Medicines: “Currently, there is insufficient evidence to recommend ivermectin for the treatment of COVID-19 patients.”
However, SAHPRA has opened the door for physicians to request their patients, on a case-by-case basis, to obtain ivermectin and what is called a section 21 authorization. This option is available for any unregistered medication.
SAHPRA is far from foolproof and is often frustratingly slow and bureaucratic. But it is a necessary institution that is currently doing the right thing. It is there to protect us all. We must not allow the wrong campaign to undermine it. DM
Geffen is the editor of GroundUp. He has a Ph.D. in computer science in infectious disease modeling.
Information regarding Covid-19, vaccines, how to control the spread of the virus, and possible treatments is constantly changing. According to Regulation 11 (5) (c) of the South African Disaster Management Act, it is prohibited to publish information through any medium with the intention of misleading people about government measures to address Covid-19. Therefore, we are disabling the comment section of this article to protect both the commenting member and ourselves from potential liability. If you have additional information that you think we should know, please email [email protected]
