A more arrogant, condescending and patronising statement than that of SAHPRA‘s on Ivermectin would be hard put to find, writes Rob Wooding.
I have read and re-read, with a growing sense of disbelief, the statement put out on the 6th of January by the South African health regulator, SAHPRA, about the use of Ivermectin against COVID-19. A more arrogant, condescending and patronising piece you would be hard put to find. The logic and justifications are devious and selective. In fact the whole thing is symptomatic of yet another state institution that is so enraptured with it’s power and self esteem that it has completely lost touch with what it is meant to be and do.
Section 2A of Act 101 of 1965 unambiguously states that the purpose of the authority is to control medicines in the public interest. Section 2B(1) goes on to say that it must ensure efficient and effective evaluation of quality, safety, efficacy and performance. Note the order. It is not random. Quality and safety THEN efficacy and performance.
At the outset SAHPRA sweepingly states that “In terms of safety and efficacy there is no evidence to support the use of ivermectin”. Really? Efficacy maybe but safety? No evidence? This medicine is decades old, is widely used throughout the world on both animals and humans and I can find no significant safety issues. SAHPRA list a whole raft of side effects but omits to say these are invariably minor and rare, and after all, that is why it is a prescription drug.
They ramble on at length about how they want to receive gold standard evidence that it works, how no applications have been received, that in “a few months” more data should become available, etc.. They are being completely reactive where, if they had the public interest genuinely at heart, they would be proactive.
In the light of current circumstances there is nothing whatsoever to prevent them making their own assessment of the safety issue alone and authorising use of the drug to see if it works. Instead we read the platitudes in the final paragraph. They would like to see a trial. They will “consider enabling” special requests “providing such a request is supported by” a whole raft of supporting documentation. Oh, and they will “expedite the review” which, in the unlikely event that they manage a forty fold improvement on the typical approval timeline, might take six weeks. This is NOT behaving in the public interest.
These people are completely out of touch with reality. At the very least the 10 medically qualified members of the council should be obliged to take a front line refresher course. Two typical consecutive 24 hour shifts at a middle tier hospital would do it.
Let them remember what it is like to have two meals and three hours of sleep in the 48. To realise you have not passed urine for 14 hours because you are dehydrated and then fall asleep on the toilet when you finally do. Look at the terror in a patients eyes when the oxygen runs out and you have no more and you both know he is going to die. Helping move bodies to free up beds because the mortuary staff have run out of PPE and refuse to attend. Using blankets for that purpose because there are no more body bags. Trying desperately that night to remember what you promised to pass on to the wife of a deceased and failing to do so. THEN get into your luxury car and go back to your air conditioned office, executive chair, cups of coffee and endless meetings in your eight hour day and say “you can’t have this drug because it might not work”.
The evidence that has been published to date might not be perfect but nobody should ignore it and cast it aside but that is exactly what SAHPRA has done. The statement devotes an inordinate amount of space rubbishing the meta analysis by Andrew Hill and concludes “From the available randomised control trial evidence, ivermectin appears not to be superior to placebo in terms of viral load reduction or clinical progression. There is no evidence from randomised controlled trials for any reduction in mortality.” In the face of a pandemic the adjectives “randomised” and ” controlled” are just nit-picking.
I hope for their sake that their conclusion that Ivermectin is useless turns out to be correct because it seems to me that there is a good chance that it won’t. Hill’s analysis shows that in at least two countries it appears to have halved the mortality. What if that turns out to be the case and in six weeks time SAHPRA are forced to back track?
At the current mortality rate in South Africa that would result in 12,500 completely preventable and unnecessary deaths as a direct consequence of bureaucratic lethargy. For every death there will be left behind at least two grieving and resentful dependants, widows, children, relatives or lovers. That will be 25,000 people with good reason to have an utter and implacable loathing and hatred for SAHPRA and everyone who serves on it. Personally, if I was on that council right now I might be feeling a bit vulnerable.
There is really a broader issue at play here. I think we really are being badly let down by a large portion of senior medical science that has sold it’s soul to the state. Both public and private. Note that I said senior.
One sort of expects employees at state institutions like SAHPRA, NICD, SAMRC, provincial and national health departments and of course the various committees theoretically advising the government to have been cowed or bribed into submission (although I suspect there is a fair chunk of complacency lurking in there as well) but it bugs me that the private sector seems to have joined the club. They have abjectly accepted the governments muzzle on information and freedom of action and God knows, at times like this, we need all the information and innovation we can get.
There is a clause in the South African version of the Hippocratic oath that says “I will endeavour at all times to defend my professional independence against improper interference”. I reckon that the moment they acquiesced to the first confidentiality agreement or directive they were breaching that oath. And with it comes lethargy. If you can’t broadcast your information, theory or discovery for all to see or benefit, why bother doing it? Note the plentiful videos, commentaries and forums on the web from all sorts of private doctors and scientists overseas. From South Africa – pretty much nothing.
Exceptions to the lethargy seem to originate at a very junior level. It takes an ordinary nurse at a private hospital in Durban to sound a warning about a possible new mutation to the doctor in charge of her ward, who passes it on to a young, junior professor from Nelson Mandela Bay who tips off a colleague in the UK that leads to the discovery of the UK variant which they now acknowledge they would never otherwise have found. And it takes the New York Times to find out about it and publicise it.