La Stampa has launched a very acutely in-depth investigation studied by Giacomo Galeazzi after receiving a letter from Mrs. Sabrina Cavallo, the mother of a 15-year-old boy who a year and a half ago was diagnosed with a genetic disease: Autosomal Dominant Polycystic Kidney (ADPKD, the acronym of the disease derives from the English ). This syndrome causes kidney failure through the continuous propagation of cysts in the affected organ. These cysts, in addition to dramatically increasing the size of a kidney, perforating themselves cause severe pain,
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similar to renal colic. After years of studies, Japanese researchers have found a medicine (Tolvaptan) capable of slowing the growth of kidney cysts in the polycystic kidney, preserving its functionality. In Europe, many states have begun to treat the sick with the drug Tolvaptan and on 17 March 2016, AIFA included it in band C, i.e. among the medicines that are not reimbursable by the national health service and therefore completely paid for by the patient. And this at unsustainable costs: from 5800 to 1160 euros per month, depending on the dosage.
The boy's mother laments "yet another injustice to the detriment of those who only ask to be able to live a dignified life". And he fears that there are interests of pharmaceutical companies in favoring profitable dialysis: the cost of the kit for each dialysis patient is 400 euros and is supplied by a single pharmaceutical company. And this at the expense of experimental pharmacological treatment.
1) Can health be treated like any other commodity?
2) Can the price of drugs be left to market fluctuations? Shouldn't Politics be the one to redistribute?
THE CASE OF TOLVALPTAN
Let's try to distinguish the three different levels of the problem. First of all the legal one: in the Constitution the art. 32 recognizes health as a fundamental right. The cure does not boil down to a do or not do, but it is a value that the Order is called upon to protect. The Constitution, guaranteeing free care to the "indigent" makes an inclusive speech. It is therefore difficult to justify the non-free administration of Tolvalptan which is an "orphan drug", approved by the EMA (European Medicines Agency). It has the characteristics to be included among the free medicines by the National Health Fund.
Then there is a moral ethical level. Healthcare cannot be managed as a market society in which everything answers the question: "how much does it cost?". What relationship (even in terms of costs) exists between technology, drug policy and human care? The mother should ask Aifa for an extraordinary measure. It is a (moral) right for the whole of society to save the dignity of the sick boy.
The most delicate point remains, the political one. Pharmaceutical companies finance research, impose patents, set prices. The convention of drugs has always generated corruption. Why do University research patents remain exclusive to pharmaceutical companies and are not shared? There are drugs, such as those to treat hepatitis C, which in Europe are prohibitively expensive, while in other corners of the world they are bought cheaply. Why?
For this boy, Aifa could have the drug administered in the hospital. Certainly the carriers of "orphan" diseases will grow. And the costs to the state are very high. A healthcare industrial plan is urgently needed to guarantee sustainability based on the principles of quality, safety, equality and effectiveness. A new social pact of solidarity must also be found between the high and poor income brackets.
Francesco Occhetta – Last Voice – 03/14/2017
Related news: FDA Issues Drug Safety Alert for Samsca, Citing Risk of Liver Injury
AIFA. Important Information Note on Samsca (tolvaptan) (20/05/2013)
EMA. Summary of product characteristics
Tolvaptan case, Melazzini (Aifa): reimbursable only to those who can benefit from it
