The new treatment for childhood bronchiolitis, Beyfortus: ineffective, expensive and dangerous

2023-10-25 13:06:37

In recent times there has been a lot of talk about Respiratory syncytial virus (VRS). And there is a promotional campaign, marketing, to sell the new treatment against it, which is called Beyfortus (nirsivamab).

They sell it as a preventive remedy, to prevent hospitalizations for bronchiolitisbut in reality you will have to go to the hospital because it is an injection and requires a professional to apply it.

It is drug is a monoclonal antibody indicated in infants and newborns during his first VRS season (this is the only indication). It is produced in Chinese hamster ovary cells using recombinant DNA technology. It’s a type of protein which is designed to recognize a specific structure (called an antigen) and bind to it.

Nirsevimab binds to a protein called “F protein” on the surface of RSV. When nirsevimab binds to this protein, the virus cannot enter the body’s cells, especially those in the lungs.

It is medication is subject to additional monitoring, to expedite the detection of new and possible adverse reactions not detected in clinical studies on its safety. Therefore, it includes a special warningthe one with the black triangle.

And why so much concern? Well, because it is a drug administered to babies and they have been reported severe hypersensitivity reactionsincluding the anaphylaxis, with monoclonal antibodies. It is therefore under observation, or in other words: The tests on its usefulness continue, only now with those who wear it.

They are also associated with the product “Clinically significant bleeding disorders”, according to its technical data sheet. As with other intramuscular injections, nirsevimab should be administered with caution in infants with thrombocytopenia or any coagulation disorder.

The safety data is worrying and the Mortality from bronchiolitis is very rare. This pathology is bronchial respiratory difficulty. Most children do not need to be hospitalized because the disease progresses like a cold with some difficulty breathing.

But at least, this medicine will be effective, right? Well, the main study on its effectiveness, carried out by the product manufacturers, Sanofi y AstraZenecacalled Melody, concludes that it has no impact on hospitalizations.

And the Extremaduran Drug Evaluation Service, EvalmedAfter reviewing Melody, he warns:

No statistically significant differences were found between both groups [el que recibió el tratamiento durante las pruebas y el que fue asistido con placebo]for 150 days of monitoring.

And do you know what is the most effective way to prevent bronchiolitis? Well, something as simple and natural as breastfeeding! So This study indicates made in Spain.

Oh, and finally, the topic of conflicts of interest. Between the doctors who are promoting this treatment is the pediatrician Federico Martinón who has received from the pharmaceutical companies 283,573 euros, in two years (Pfizer, GSK, Sanofi o AstraZeneca).

Wow, we are probably facing a new economic-health hit, this one is even more serious because it is playing with the health of babies. And it is done using a drug with no proven efficacy, dangerous and expensive since it costs 220 euros (if applied to the entire population).

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