Aifa: Reflections on the functions and work of the Italian Medicines Agency

Aifa: Reflections on the functions and work of the Italian Medicines Agency

We take inspiration from the airing of an excellent television service by the Report program, aired on October 28 and having as focus the contamination of raw materials used for drugs marketed (also) in Italy, to reflect on the function and work of Aifa, the agency for the control of the drug in our Country.

Let's see how, from the Nitrosamine alarm to the accusations of the Court of Auditors, from the public declarations to the actual lack of data, the work of this Agency probably deserves a little more clarity.

We remind the reader that Aifa is the Italian Agency of the Famaco, an institutional body therefore, responsible for the verification and control of every drug placed on the market in our country (including vaccines); therefore she who should guarantee the safety of every medicine prescribed and sold on the national territory.


Nitrosamine alarm

It is 13 September 2019 when Ema, the European Medicines Agency, launches a warning on medicines containing the active substance "Ranitidine": according to "tests" (not better specified as to origins and clients) these medicines could be contaminated from N-nitrosodimethylamine (Ndma), or nitrosamines, substances known as probable carcinogens for humans, (as it is written, but in the report aired on Rai we learn that they are powerful carcinogens, which at least 300 different have been described of nitrosamines , 30 of these are certainly carcinogenic and 4 of these 30 have been found in drugs ...).

In this first release it is reported (from Aifa website) that "EMA is reviewing the data to assess whether patients using ranitidine are exposed to any risk due to NDMA, and will provide information on this as soon as it is available."
By downloading the pdf made available by Ema we also read that "In 2018 NDMA and other similar compounds, known as nitrosamines, were detected in a number of medicines used for hypertension called" sartans ", which led to the recall of some medicines from the market and to a revision at the level of the The European Union, which has established new and restrictive requirements for the production of these drugs. The EMA is currently working on a guide to avoid the presence of nitrosamines in other classes of medicines. The EMA will continue to cooperate with the authorities. national, EDQM and international partners to protect patients and ensure that effective measures are taken for the presence of these impurities in medicines. "

Shortly afterwards it will come out another release intended for companies where a specific production site in India will be identified as "at risk", asking manufacturers to check whether the raw materials they use come from this factory or not.

So this alarm derives from data available already in 2018, but the communication dates back to September 2019. In the meantime, hundreds of thousands of people have continued to take mecidinals (mainly antacid and antihypertensives) unaware of the danger to which they were potentially exposed ...

It is then on September 20 when Aifa orders the withdrawal from the pharmacies of all medicines happy with Ranitidina, and not only that produced in that particular Saraca plant: "As a precautionary measure, AIFA has also prohibited the use of all batches marketed in Italy of medicines containing ranitidine produced by other pharmaceutical workshops other than SARACA LABORATORIES LTD, pending analysis". Again as a precaution, as you can see ... but here the contaminations are well known, as reported by the authors of the Report in the service.

Finally, on September 26, Ema publishes a press release stating that "The EMA Committee for Medicinal Products for Human Use (CHMP) is requesting as a precaution that the marketing authorization holders (AICs) of medicinal products for human use based on active substances produced by chemical synthesis review the own medicines for the possible presence of nitrosamines and test all products at risk. "
So to be tested they will have to be all drugs for human chemical synthesis and not just those "suspected" until a few days before.

What emerges from the television service is that the active ingredients that are used by pharmaceuticals worldwide, come from laboratories that are somewhat deficient in terms of hygiene and sanitation and are lacking in requirements to guarantee the absence of contamination and, therefore, the security of the product which is then sold at bargain prices to the industries holding the marketing authorizations for the finished product.

But all this, does not raise anyone's doubt that something is not working as it should in the control mechanisms ???

How is it possible that, out of the blue, the presence of carcinogens is discovered in drugs for daily use and NONE of the Authorities had noticed it, before a German "team of independent experts" (so we learn from Report ) publish the evidence ???
Base note, this team of experts used, for these verifications, the same instruments used in some of the analyzes commissioned by Corvelva on the vials of vaccines (mass spectrometry), instruments here defined at the forefront... but according to Aifa our analyzes have no value ...

Let's move on, and see what's interesting about Aifa's reliability by watching this TV report ...
The general manager of Aifa, Luca li Bassi, is interviewed and his words "season" the television service in several passages; hence we learn that:
- Aifa carries out around 250 inspections per year to pharmaceutical companies, pursued by the reporter who asks "But do the inspected companies know that you are coming to inspect them?" and "out of 10 inspections how many are surprise and how many are announced?" the answer of the general manager of the Authority is that "honestly most are announced. " How we can guarantee the effective effectiveness of these inspections starting from this assumption seems a mystery to us.
- Always Li Bassi says that "The finished product is tested by companies", "company tests are done according to methods" and the reporter informs us that in 2017, out of 7.000 drugs on the market, Aifa checked just 78 batches .... What guarantees can arise from these small independent checks? How can you think, on such delicate issues that concern billionaire business, to trust the tests carried out by pharmaceutical companies, the same that should be controlled ???


Investigated by the Court of Auditors

Here is another interesting food for thought that comes to us from the news of the last few days.
"Aifa executives investigated by the Court of Auditors, tax damage of 200 million euros", so reads a recent article published by Quotidiano Sanità, which you read here

"The in-depth analyzes - it is read - have made it possible to ascertain how, despite comparative studies having demonstrated the substantial therapeutic equivalence, in terms of efficiency and safety, of the drugs AVASTIN and LUCENTIS, the non-inclusion of the former - until 2014 - among the reimbursable products by the National Health Service or the unjustified limitations subsequently imposed on its use - until 2017 - caused significant additional expenses for the Treasury ".

“The economic burden - specifies the Finance - was calculated based on the difference in the price of the drugs, between 600 and 730 euros per single dose, in relation to the total number of treatments carried out with the more expensive LUCENTIS. The recipients of the measure, which was assessed at the time, both from a technical-scientific and economic-financial point of view, on the inclusion of medicines in the list of those reimbursable by the National Health Service, now have 60 days to provide defensive deductions to the magistrates of the Court of Auditors ".

"With reference to the commercialization of AVASTIN and LUCENTIS, in 2014, the Competition and Market Authority had already imposed an administrative sanction of over 180 million euros against pharmaceutical companies for a restrictive agreement on competition, for having agreed an artificial differentiation of products, presenting the former as more dangerous than the latter and thus influencing the choices of doctors and health services ".


What evidence on the vaccine front?

As for the matter of biological drugs, and more specifically of the vaccines - which in Italy have been made mandatory for the pediatric population by a 2017 law, 119 - we observe how the obsessive media campaign aimed at painting them as "very safe and very effective" now boasting hundreds if not thousands of articles on online and printed publications; all efforts seem focused on persuasion of the Italian population of the fact that these drugs are the safest, most effective, irreplaceable means of prevention from various diseases. Too bad that the very few active pharmacovigilance programs paint a completely different picture, so much so that - to be in good faith - one wonders why these programs are not regularly implemented and foreseen for each recommended vaccine ... they cost too much, perhaps, but saw thereincrease suffered by the cost of vaccines after the so-called "Lorenzin law", money should not be lacking, and if checks and research are entrusted to pharmaceutical companies, why should a contribution "donated" to pharmacoviglance (but serious and independent) conducted by the Italian State not be asked ? Tips thrown in there, it's just an idea. The last active pharmacovigilance report we have available is that of the Puglia region on the mprv vaccine (published in 2018) and reported adverse effects for 4 out of 100 children!

However, the latest press release on the issue from Aifa concerns the possible presence of latex, but not inside the vaccines! (as they want to specify in a note) but in the wrappers. Again, we are not talking about independent analyzes carried out on vaccines that would have led to an alarm: as we read, in fact "AIFA has in any case considered it appropriate to contact all the AIC holders of the anti-flu vaccines authorized in Italy, asking to certify, where not specified in the Summary of Product Characteristics (SmPC) and in the Package Leaflet, the presence of latex in the components of primary packaging. "
And since the articles released on various newspapers left room for misunderstandings, they decided to emphasize: The notice published by AIFA concerns only the packaging of flu vaccines to protect those who have allergies to this substance. This is to allow allergy sufferers adequate vaccination by informing them of latex-free products. So no contamination in the flu shots. "

But one question continues to remain devoid of concrete answers: the "batch by batch" checks and their results, the "independent analyzes" carried out, where are they? There are? can we see them? to have evidence of it?

Because, when it is declared that the analyzes commissioned and paid for out of pocket by an association of Italian citizens "do not provide useful data for a scientific evaluation" because "The analysis methods used to verify the quality of the vaccines and the presence of any contaminants must be certified and comply with the shared procedures and requirements at European and international level based on the scientific knowledge available" and yet that "The competent authorities carry out checks throughout the vaccine's production cycle. Furthermore, before distribution on the market, each single batch is subjected to a further double check carried out independently, both by the manufacturing company and by an international network of laboratories. accredited " it would perhaps be appropriate to make these results available to taxpayers (and recipients of an obligation), or at least the data that would contradict what has been exposed (and reported to the Public Prosecutor's Office with - obviously - original data and laboratory certificates) from the association. In relation to this, we have limited ourselves to these public replies, but no excerpt of analysis has been shown in contestation of what we have reported, nor at least to mention numbers or dates of the checks carried out, just to give at least some "fixed point" and concrete to these replies in words.
However, we would like to underline that the latest reports published by Corvelva contain the results validated through control standards and interlaboratory confirmationstherefore, we are faced with citizens who, from their own pockets, continue to investigate the silence of the institutions that should guarantee the safety of these products, all the more so, I emphasize it again, when these products claim to be administered obligatorily and in the pediatric range.

In light of all of the above, the work of Aifa leaves us as perplexed as the attitude of closure and guilt that the institutions hold before a part of worried citizenship that asks only for answers, which are clear and complete with data verifiable.


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