Monday 21 June 2021

Covid-19 and Vitamin D : Politics and the influence of the US FDA

Covid-19 and Vitamin D : the influence of the FDA

In March 2020, the pandemic of Covid-19 was causing chaos in the hospitals of Europe and elsewhere, a major logistic challenge being the large number of critically ill patients with Covid-19 pneumonia (lung disease) requiring ventilatory care. The approach of the UK and other governments was to commission and buy more ventilators and even emergency hospitals (Nightingale hospitals in the UK). This gross oversimplification of the action required was easily made by politicians who regarded hospitals as automated factories, unaware of the need for large numbers of skilled doctors and nurses to provide the intensive and ventilatory care that would be required. 

Some medical practitioners and scientists had a knowledge of the importance of defensive immunity in minimising the effects of a new virus to which we had no historic immunity. The details had been worked out during the previous 40 years, and were available for all to read. It was clear that vitamin D has a pivotal role in escalating the cascade of defensive immunity.

Previous evidence was available that deficiency of vitamin D is very common, in the UK, in Europe generally, and indeed world-wide. It was also clear that vitamin D deficiency is particularly common and serious in the elderly (whose dry skin is unable to produce vitamin D), in people of black and Asian ethnicity living in the UK and other north European countries, and in the obese.

Why was this knowledge not applied when the pandemic started? Surely the best brains of the nation were at work, and they would have known that the best immediate defence would have been to optimise as soon as possible the defensive immunity of the population, especially those at particular risk – the elderly who were to die from Covid-19 in large numbers. Why was the opportunity to minimise these deaths completely missed?

WHO and failure of duty

It must have been the duty of Public Health England and other national public health bodies worldwide to take immediate action to correct widespread vitamin D deficiency, but it must also have been the duty and responsibility of the World Health Organisation. It was not to be. The WHO even redefined "immunity" so as to exclude natural (vitamin D associated) immunity and acknowledge only man-made immunity, that is vaccines. It later decided to recognise both. But it was clear that the objective of the WHO would be to support the development of "vaccines" to the exclusion of all other medications. Why was this? Why was vitamin D deficiency and its correction to be ignored?

It should be noted that the approach of the much-applauded new experimental gene therapies is to develop immunity against a specific virus, but strictly speaking they are not vaccines. However, the term "vaccine" is more acceptable to the population than "gene therapy", and so this description is used.

Many clinical doctors would be aware of the importance and extent of vitamin D deficiency, and the automatic clinical duty of a doctor to correct it. How could the WHO control and suppress the prescribing of vitamin D by these clinical doctors? 

WHO policy

The key to understanding what happened concerning the denial of vitamin D lies in the WHO policy of "vaccines for the world population". The problem was that vaccines take several years to develop and then to test for both effectiveness and safety. 

The vaccines would not become available until the end of 2020 at the earliest. However even though short-term evidence of benefit might be available by that time, full demonstration of safety would take much longer and so licensing for use could not be anticipated. It was therefore necessary for the vaccines (each one) to be issued with Emergency Use Authorisation (EUA) by the US Food and Drug Administration (FDA). This was achieved with clinical trial evidence of reduction of incidence of Covid-19 following vaccination. Several vaccines received authorisation in this way during the following six months.

The US EUAs were followed by emergency use authorisations being issued by UK, EU, and other national agencies. An extremely well-organised roll-out of vaccinations followed, the objective being world population vaccination by the end of 2021, on the basis of EUAs and without licences.

The granting of an EUA acknowledges that the medicine / vaccine concerned is still experimental. The EUA is granted on the basis of the clinical experiments, the controlled clinical trials, being continued so as to demonstrate the incidence and range of untoward events in the two groups, the vaccinated and the controls. Only in this way could the safety of the vaccines be demonstrated, by comparing those who had received the vaccines and those who had not.  

Unfortunately this has not happened and will not happen because at the end of the initial clinical phase, the unvaccinated controls were "unblinded", and the great majority appear to have been vaccinated at this stage. The controls ceased to be and so the long-term safety evaluation will be uncertain. A clear and detailed account of this process written by Peter Doshi, senior editor of the British Medical Journal, was published on-line on May 18th 2021

FDA rules and Vitamin D

To understand the implication of the EUAs and their effect on the use of vitamin D, it is necessary to read the small print of the FDA rules for the granting of an EUA. The rules state that:

"For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition.

As the decision had been made from the onset that vaccines were to be developed (at great cost), and ultimately by more than 50 companies in the world, it was essential that there must be no obstruction to the EUAs. Was there in reality an available alternative to the vaccines for prevention or treatment of Covid-19? 

In March 2020 there could not possibly have been any evaluation of specific medications in the treatment and prevention of Covid-19. There were a number of possibilities, based on the experience of other infections, bacterial and viral, and basic science. It was clear from basic principles that the first level of defence against a virus infection, especially a novel virus, is the innate immunity of the body. There was much understanding of the processes involved, and the pivotal role of vitamin D in its active forms in the escalation of defensive immunity. It was also known that deficiency of vitamin D was very common, especially in the groups that would be very badly affected as the pandemic unfolded. It had also been demonstrated before the appearance of Covid-19 that vitamin D supplement would reduce the incidence of respiratory infection.

So here lay a problem. How could EUAs for vaccines be granted with vitamin D being readily available? It had to be buried out of view of the public and their officials. In particular successful clinical trials of calcifediol, 25(OH)D (activated vitamin D) had to be "censored". 

The suppression of knowledge of vitamin D has been a great achievement and triumph of officialdom. Vitamin D deficiency has been ignored, irresponsibly so in the elderly, in the obese, and in people of black or Asian ethnicity. The denial of this scientific knowledge can be regarded as a crime against humanity. There were more than 75,000 Covid-19 deaths in the UK during 2020, and those who died were not given the opportunity or the choice to receive vitamin D. There was no public health policy to test for vitamin D deficiency, knowing of the high prevalence and importance of such deficiency at this time. In practice the testing of blood levels of vitamin D was discouraged.

The achievement of the introduction of vaccines with just Emergency Use Approval was at the cost of many deaths, especially of the known at risk groups, that might have been prevented by the  correction of vitamin D deficiency. 

The importance of vitamin D deficiency has been shown in a study from Israel

There was a 3% death rate in those admitted to hospital who were not vitamin D deficient. However those who were severely vitamin D deficient (<10ng/ml, <25nmol/L) had a 14 times greater risk of critical disease and 25% died.

During the pandemic we have seen many careful observational studies of the great disadvantage of vitamin D deficiency, which could have been corrected rapidly, cheaply, and safely. This was not done so as not to jeopardise the issue of EUAs to the vaccines.  

Vitamin D deficiency was not even considered, and official pronouncements referred (always negatively) to "vitamin D supplements", never referred to the correction of vitamin D deficiency, and always denied the role of vitamin D in the escalation of defensive immunity.

The "sensible" approach at the onset of the pandemic would have been to correct vitamin D deficiency immediately, with priority to the elderly and the black and Asian ethnic groups. This would have protected the population during the course of 2020 until the vaccines became available, but FDA rules meant that this sensible and responsible policy was not to be.

The rule meant that exclusion and silence were also applied to Ivermectin and Hydroxychloroquine, both of which had been shown to be effective against Covid-19.

After FDA Emergency Use Authorisations

In mid-2021 vaccines are still being given on the basis of EUAs. No vaccine has yet received a licence for use. The EUAs mean that if there are any untoward effects, responsibility and compensation will be the function of governments who issued the EUAs, and not the pharmaceutical companies themselves. This can be of only good news to the companies.

How long can an EUA continue before a licence becomes necessary? It is far from clear and at this stage the FDA is unlikely to call a halt to mass vaccination while awaiting licensing. However once licences are granted vitamin D can emerge from seclusion and come into clinical use and correct the widespread deficiency that has been highlighted during the pandemic.

But there is another problem. Licensing will require full evaluation based on continuation of the randomised controlled trials, on the basis of which EUAs were based. But of course it took just a short time, about two months, to demonstrate a reduced risk of Covid-19 in those receiving a vaccine compared to controls. It would take much longer to demonstrate safety. 

Adverse event have occurred in some people who have received vaccines, events such as pulmonary emboli or even death. They have generally been dismissed as "coincidences", that they would have happened if the vaccines had not been given. The usual approach would be to compare the event frequency in the vaccinated group with the event frequency in the control group. Simple, but not possible now. At the end of the first stage of the controlled trial, the randomisation code was broken, and the control subjects were given the opportunity to be vaccinated. The vast majority took the opportunity. 

This means that there is no longer a control group. Randomised controlled evidence cannot be presented to the FDA and similar licensing authorities. Safety considerations will be seriously curtailed. Can EUAs be continued indefinitely? This might be acceptable to companies from whom financial responsibility has been taken by governments.

The pharmaceutical companies that gave vaccines to the control subjects state that they did so for ethical reasons, and these are understandable as there are ethical constraints on controlled trials. Controls can become sacrificial victims to "the truth", as I have pointed out in a previous post

It is understandable that with-holding vaccines from controls once benefit had been demonstrated was considered to be ethically unsound, but it puts the FDA in a difficult position concerning licensing. However the same ethical approach to vitamin D / calcifediol trials was used to dismiss these trials from public view and practical application.

The vaccine developments have been remarkable, but the dismissal of vitamin D and the correction of its deficiency has been a disgrace.

A failure of WHO

I mentioned that the WHO needed to prevent doctors from prescribing vitamin D, but this is not actually correct. It would have been accepted and indeed ideal if doctors were to prescribe and encourage vitamin D, as long as it was beneath the FDA radar, as long as it was done on the quiet so that EUAs could continue.

Although there has been continuing official denial of the benefits of vitamin D, there has been a strong "grass-roots" movement. Sales of vitamin D in pharmacies and health food shops have escalated during the pandemic, including the ideal doses of 2,000 to 5,000 units daily. Many clinical doctors have told me that "We are all taking vitamin D", and recommending it to their patients. This includes hospital doctors. This is good news and it will have contributed to the very low number of deaths from Covid-19 during the Spring and early summer of 2021, the onset of the Vitamin D Production season.

With vitamin D being given in good dose unofficially, any benefit from vitamin D would not be measured and the totality of benefit would be attributed to "official" actions: lockdown and vaccines. The leaders of the nation and their medical advisors would welcome the increase in the number of people taking vitamin D, even though they would deny knowledge of it.

June 2021

The overall great improvement in the immunity of the UK and other populations is shown in the figures below, a comparison between 2020 and 2021. The number of deaths per day is now very low. In the UK an average of about 1,600 people die each day, and so five Covid-19 deaths should not cause great alarm.

The numbers of hospital and ICU admissions are also very low, again a great benefit of improved immunity. The number of cases has risen in recent weeks, probably the result of more freedom of the people. This time in 2020 we were in serious lockdown with very little road traffic. The increasing traffic density now is a measure of freedom of travel and relaxation of mixing rules. "Cases" are not easily defined, but as there has been a policy of more Covid-19 tests for all, no doubt most of the cases will be asymptomatic positive tests.

UK: daily deaths from Covid-19, 2020 and 2021

UK: daily cases of Covid-19, 2020 and 2021

The increase in the number of cases now is much less than in January 2021, a peak that has not been satisfactory explained.

UK: daily cases of Covid-19, November 2020 to June 2021