AIFA limits the prescription of vitamin D: Annamaria Colao, president of Sie, explains the reason, but also the usefulness of the vitamin itself
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The hiring of vitamin D “for several years it is not able to modify the risk of fracture in the healthy population, without risk factors for osteoporosis”. It was written in black and white by theAifathe Italian Medicines Agency, in the use 96/2023, just published in the Official Journal. In fact it is one partial reverse on the positive effects of vitamin D in the prevention of risk of fractures. The update derives from the analysis of two studies, an American one (Vital) published in Nejm in 2022, and a European study (Do–Health) announced in 2020 in Jama magazine.
In the document, Aifa also reduces da 20 a 12 ng/mL (or 50 to 30 nmol/L) the maximum level of 25-hydroxyvitamin D serum (the one provided for in most supplements), necessary for reimbursement purposes: in short, above these thresholds the National Health Service no longer reimburses the supplement.
Among the other innovations, provided for in the note, there is also a paragraph dedicated to the link between the benefits ofhormone and the Covid-19. Here are the clarifications of the president of the Italian Society of Endocrinology (SIE), Annamaria Colaoin an interview granted to Virgil News.
The effectiveness of vitamin D in the fight against Covid has been denied by AIFA: what does it mean?
“It is a statement consistent with what are the characteristics of vitamin D. We know, in fact, that it is a immunomodulatore powerful, which means that it has a positive effect in strengthening the immune system, but this does not mean that it is used to fight the Covid disease: in other words, if you are ill you must follow a therapy which includes antivirals or monoclonal antibodies, depending on the case. Certainly not the only vitamin D, which in case could serve to increase the immune system before the infection (by the way, here are the foods in which to find vitamin D, ed. The studies conducted so far say that it can have this effect. It is different to think that it is a cure. In short, if it is true that ‘An apple a day keeps the doctor away’it is not equally true that if you eat an apple a day you will never get sick”, explains Colao.
According to Aifa, an assumption of years does not change the risk of fracture in the healthy population, without risk factors for osteoporosis: what do you think?
“The answer involves one small premise. Aifa’s note follows the evaluation of two studies, conducted on a large population followed for 3 and 5 years, analyzing the risk fracturing, therefore of bone fractures. The problem is, while studies conclude that taking vitamin D it didn’t affect in risk reduction, they did not also take into account other determining factorssuch as the lifestyle of the populations that have been examined”.
Can you give some examples? What could have influenced a higher or lower probability of fractures?
“The possibility of problems depends on the bone quality which in turn depends how it was fed and how one has grown up to the age of 30, the age after which the bone no longer grows and can only be ‘lost’. This concretely means that it has not been evaluated, for example, if and how much one has been exposed to sunrays, which are the ones that stimulate the production of vitamin D. The same goes for the lifestyle, because you haven’t taken into consideration what you are ate, if the intake has been sufficient, or if sufficient time has been spentopen air – explains Colao -. What we can certainly say is that in a sample of average age between 50 and 60 years, such as that of the two studies, vitamin D alone does not protect against the risk of fractures”.
Annamaria Colao, president of the Italian Society of Endocrinology (SIE)
Is vitamin D, in terms of supplements, still useful after the age of 50?
“What needs to be clarified is that Vitamin D, in supplemental form and by itself, is not a curebut if anything it is a form of prevention that should be followed during the growth phase, in short within the age of 30. It can serve, depending on the case, to avoid the rickets in children or it can be useful for donne pregnant. In short, it is not a therapy, but a form of prevention, but it would be incorrect to say that it is useless”.
Why then did Aifa decide to restrict the possibilities for reimbursement by the National Health Service?
“From an economic point of view Aifa’s position can be understandable, with a view to necessary savings for healthcare, starting to cut back on what you are not sure about. But I would invite one greater caution for two reasons: the first is that vitamin D weighs very little on the coffers, but on the other hand it intervenes on the general state of health of the person. The second reason has to do with this: in terms of prevention, as I explained earlier, vitamin D intervenes in risk reduction of major diseases. Metabolic ones like the diabetesthe cardiovascular ones (a stroke from a heart attack), oncological or autoimmune. In short, if a person develops theallergytake vitamin D it doesn’t heal herbut hiring it can help to prevent the onset of other pathologies or al reduce its effects”. concluded Colao.