|July 2021. The UK is enjoying an excellent summer, hot and sunny, no climatic catastrophies|
Covid-19 and Vitamin D
On September 3rd 2020 the UK had experienced 43,693 Covid-19 deaths, one of the highest deaths per million in the world. The hospitals had been quiet during the summer, the season of vitamin D production and high immunity, but as winter was approaching Covid-19 cases and deaths were about to increase.
|UK: Covid-19 deaths per day during 2020|
On this day we received a report from Córdoba, Spain, that vitamin D in its part-activated form 25(OH)D, calcifediol, had been remarkably successful in patients admitted to hospital on account of Covid-19 pneumonia. This is just what we needed and it caused great excitement in those who had read the report and who were anxious to reduce deaths.
It is necessary to understand a little of the metabolism of vitamin D. The oil 7-dehydro-cholesterol (7-DHC) is synthesised in the skin, and when the UV energy from the Sun is strong enough in the summer months it converts 7-DHC into vitamin D by splitting a specific inter-atomic bond. It is also important to appreciate that the thin dry skin of the elderly produces inadequate amounts of 7-DHC and so vitamin D deficiency is inevitable in this age-group.
Vitamin D produced in the skin is transported in the blood to the liver. A slow process then takes place in which an -OH group is added to the molecule to form 25(OH)D, also known as calcifediol. It is the same after vitamin D is taken by mouth, the process of activation taking up to two weeks.
|It takes two weeks for blood level of 25(OH)D to increase above 30ng/ml following different oral vitamin D regimens.|
This presents no problem in the steady state of normal life. However it presents a serious problem to someone who meets a sudden serious illness, and to many people at the time of a pandemic that is due to a new virus to which we have no historic immunity. Under such a circumstance immunity must be optimised immediately but this is not possible for someone who is vitamin D deficient. The escalation of immunity is likely to fail, the consequence being worsening illness, cytokine storm, widespread damage, the need for ventilatory care, and a high risk of death. This was the situation facing the 43,693 Covid-19 patients who died in the UK before September 3rd 2020, and many others who survived serious illness.
As the escalation of immunity is of the greatest urgency, vitamin D itself cannot be expected to help. It will take much too long to become adequately activated. If someone has bacterial pneumonia it is of little value accepting a two week delay before giving the life-saving antibiotic. The vital disadvantage of delay was demonstrated in Brazil. In a controlled trial vitamin D was given to 102 patients with Covid-19 on an intensive care unit, and a 120 acted as controls. The main endpoint was the time to discharge from hospital, and there was no difference between the two groups.
This trial was widely reported as indicating that "vitamin D is of no value". This was ideal news for those who wanted vitamin D to be buried. But the paper made no mention of the metabolism and activation of vitamin D. It also made no mention of the clinical trial in Córdoba, and no acknowledgment of the obvious metabolic advantage of calcifediol.
The Córdoba trial showed a very positive benefit from calcifediol, which had been used in an imaginative way, knowing that at the stage of serious Covid-19 pneumonia "raw" vitamin would act too slowly to be of benefit.
Instead of two weeks, calcifediol given by mouth reaches an adequate blood level after about two hours. The difference between "raw" vitamin D (cholecalciferol) and 25(OH)D (calcifediol) is obvious in terms of dynamics and effectiveness. The great potential superiority of calcifediol is easily understood.
|25(OH)D, calcifediol, achieves blood level greater than 30ng/ml after just two hours|
Of the 76 patients admitted to hospital on account of Covid-19 pneumonia, 26 were controls, being given standard high quality care. 13 (50%) required transfer to ICU and 2 died. 50 patients were given Calcifediol in addition. 1 (2%) required transfer to ICU and there were no deaths.
This huge benefit from calcifediol was clear, but once again vitamin D had to be buried from human view, for reasons explained in a previous Blog post: if vitamin D/25(OH)D were to be effective, then vaccines could not be given Emergency Use Authorisation. It was the UK National Institute for Health and Care Excellence (NICE) that performed this service to maintain the "official" narrative, informing clinical doctors struggling to prevent deaths that the dramatic result of the Córdoba study must not influence clinical practice. And so it happened: calcifediol was not used. There was no debate. There was no "peer review". NICE could not be challenged. Clinical doctors had lost their ability to assess risks and do their best for their patients.
The use of calcifediol has no disadvantage, only benefit, but this was not of "official" importance. The number of deaths continued to increase. The denial of calcifediol could be regarded as a crime against humanity. The patients who were to die from Covid-19 would not be given the choice of calcifediol treatment, but they will be just be pawns in a much bigger game.
Five months and 50,000 UK deaths later we received the first results of another controlled clinical trial from Spain, this time from Barcelona. A larger trial involving 838 patients admitted to hospital with Covid-19 pneumonia. 447 were treated with Calcifediol and 391 acted as controls receiving just standard high quality care.
Of those who received calcifediol, 20 (4.5%) required transfer to ICU, compared to 82 (21%) of the control group. On the basis of intention to treat, 21 (4.7%) of the calcifediol group died, compared to 62 (15.9%) controls. In practice, some of the control patients were given calcifediol following transfer to ICU. The clinical staff wanted to avoid preventable deaths, and quite rightly.
This highly significant result must be enough. The pressure on ICUs was so great that such a reduction in demand would have been very welcome, had it been allowed. Once again there was no debate within UK medicine, just a denial of benefit by Professors Naveed Sattar and Adrain Martineau on behalf of NICE. The structure of the trial was criticised for not being "perfect", a sad example of the good being over-ruled by the illusory perfect.
In practice perfection is impossible to achieve. I have illustrated previously that in both Cordoba and Barcelona, the two trial groups were very closely matched to the point that any imperfection would be over-ruled by the very large benefit of treatment.
Activated vitamin D, 25(OH)D, calcifediol remained unavailable for use in the UK and elsewhere. Patients continued to die unnecessarily.
The new experimental gene therapies, now known as vaccines, came into clinical use under FDA Emergency Use Authorisation (EUA) in December 2020. By this time 75,136 Covid-19 deaths had occurred in the UK. But we could hardly expect an instant effect from the vaccines.
In fact following the introduction of vaccinations there was an unexplained surge of cases and deaths in January 2021, reaching a maximum of 68,053 cases on January 8th and 11,062 deaths on January 7th. The surge settled and by March there were fewer than 10,000 cases and fewer than 200 deaths per day.
|UK: Covid-19 deaths per day since the arrival of the pandemic|
The organisation of the vaccines was a particular triumph in the UK but the benefit was of prevention. People admitted to hospital with severe Covid-19 pneumonia would not benefit from vaccination and would continue to have a high mortality rate despite high quality intensive care.
In the six months following the introduction of vaccines in December 2020 there were 60,616 Covid-19 deaths in the UK. It is inexcusable that vitamin D as calcifediol was not given to those who were critically ill despite the vaccination initiative, in an attempt to reduce these deaths.
It was in the first week in February 2021 that the results of the Barcelona trial became available.
The Barcelona pre-print was rejected by Professors Naveed and Adrian Martineau on behalf of NICE as soon as it appeared. Their comments were published on February 15th. There was no debate, no peer review, just the opinions of two people. The misuse of great power. They suggested that the process of randomisation was irregular and that this would invalidate the result. I have pointed out that randomisation was very successful but not quite perfect. They also complained that the paper had not been peer-reviewed. More evidence was demanded while people continued to die.
The pandemic was evolving rapidly. Urgency was essential, as was happening with vaccine development and subsequent Emergency Use Authorisation. The results of many studies of a variety of treatments were released before publication so that clinical action could be taken should the clinical staff think it appropriate. Delays in treatment should be minimal.
The initial communication from Barcelona appeared in early February 2021. On June 7th the paper was released on-line before being printed in the Journal of Clinical Endocrinology and Metabolism. It had been peer reviewed and accepted for publication but this process took four months, during which time many deaths had occurred.
Once again vitamin D as calcifediol, a natural product, was shown to be very effective and without untoward effects. Perfectly safe, very cheap, very effective. Patients treated with calcifediol had an 87% reduction in need for ICU compared to controls.
It might have been expected that we would have seen headlines in the medical journals and national press, but none appeared. At least in the UK, and apparently in other European countries and North America, the paper was dead at birth. NICE has made no comment, but news of the paper has circulated on the internet. Perhaps clinical doctors can now act and use calcifediol for the critically ill on the basis of what they have read, before NICE says "No". But professionalism has been replaced by government control. Covid-19 has become Covid-1984.
Vitamin D is powerful but only in a dose adequate to optimise the escalation of defensive immunity. Unfortunately we are up against another government institution rather than a medical professional body, the Royal Colleges of Physicians which have been responsible for medical knowledge and excellence for 500 years.
The Standing Advisory Committee for Nutrition (SACN) advises the government about vitamin D. It appears to have little awareness of the role of vitamin D and its metabolites in the escalation of defensive immunity and the suppression of the cytokine storm, mentioning just "a suggestion". SACN acknowledged only the role of vitamin D in bone maturation, recommending a low orals dose of just 10mcg, 400units each day, about a tenth of what is required for optimisation of defensive immunity.
Controversy of the correct requirement of vitamin D has caused confusion and led to problems with implementation and interpretation. When "vitamin D treatment" is mentioned, what dose or achievement is being described? Of course the achievement should be that of a given blood level. In respect of bone and calcium health a blood level of 10–20ng/ml (25–50nmol/L is adequate. Experience during the Covid-19 pandemic indicates that a target range of 40–ng/ml, 100–150nmol/L is safe and effective, but variation of thought remains. The official denial of the benefit of vitamin D during the pandemic has stifled the opportunity for definitive research.
We are now seeing an unexpected rapid increase of "cases" of Covid-19 in the UK, also in the Netherlands and Spain. The increase is also starting to show in other European countries and in the USA. This is not matched by an increase in deaths, but there is an increase in hospital admissions in England, from 100 to 500 per day.
These patients admitted to hospital could be given vitamin D as calcifediol to diminish the need for transfer to the ICUs and to reduce the numbers of deaths. But it not happening. Clinical doctors are still being denied the opportunity to use calcifediol and patients will continue to die when they need not do so.
|Why are cases increasing in 2021 at the time when they were diminishing in 2020?|