Aifa: Reflections on the functions and works of the Italian Drug Agency (AIFA)

Nassim Langrudi AIFA 22 Novembre 2019

Inspired by an excellent reportage of the TV program 'Report , broadcasted last October 28 and focusing on the contamination of the raw materials used to produce drugs sold (also) in Italy, we want to make some considerations on AIFA’s functions and actions (AIFA is the drug control agency in our country).

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

We remind to the reader that AIFA is the Italian Agency of Drugs, therefore an institutional organization, in charge of verifying and checking every drug placed on the market in our country (including vaccines); hence, it should guarantee the safety of every medicine, prescribed or sold in the national territory.

Nitrosamine Alarm

On September 13^th 2019 EMA, the European Medicines Agency, launches a notice on medicines containing the active ingredient "Ranitidine": according to "tests" (not better specified as to origins and customers), these medicines could be contaminated with N-nitrosodimethylamine (Ndma), or nitrosamines, substances known as probable carcinogens for humans, (so it is written, but in the report aired on the Italian TV Channel RAI, we learn that they are powerful carcinogens, that at least 300 different nitrosamines have been described, 30 of these are certainly carcinogenic and 4 of these 30 have been found in drugs ...).

In this first release, it is reported (from the AIFA website) that "EMA is reviewing the data to assess whether patients using ranitidine are exposed to some risk due to NDMA, and will provide information about this subject as soon as they become available".

After downloading the pdf made available by EMA, we also read that "In 2018 the NDMA and other similar compounds, known as nitrosamines, were detected in a number of medicines used for hypertension called "sartans "; this led to the removal of some medicines from the market and a review at European Union level, which established new and restrictive requirements for the production of such drugs. EMA is currently working on a guide to avoid the presence of nitrosamines in other classes of medicines. EMA will continue to cooperate with national authorities, EDQM and international partners to protect patients and ensure that effective measures are taken for the presence of such impurities in medicines."

Shortly afterwards, another statement has been released, addressed to those companies with a specific production site in India, identified as "at risk", asking producers to verify whether the raw materials that they use come from this factory.

So, this alarm comes from data already available in 2018, but the communication is dated September 2019. Meanwhile, hundreds of thousands of people have continued to take medicines (mainly anti-acid and antihypertensives), unaware of the danger they were potentially exposed to...

On September 20^th, AIFA ordered the withdrawal of all the medicines containing Ranitidine from pharmacies, and not only those produced in that particular Saraca plant: "As a precautionary measure, AIFA also forbade the use of all the lots sold in Italy of ranitidine-containing medicines produced by other pharmaceutical companies other than SARACA LABORATORIES LTD, pending their analysis". As a precautionary measure, as you can see... but here the contaminations are well known, as reported by the authors of the reportage aired in Report.

Lastly, on September 26^th, EMA published a statement specifying that "The EMA's Committee for Medicinal Products for Human Use (CHMP) is requesting, as a precaution, that marketing authorization holders (AICs) for medicinal products for human use based on active ingredients produced by chemical synthesis revise their medicines for the possible presence of nitrosamines and test all the products at risk."

Therefore, all chemically synthesized drugs for human use should be tested, not just those "suspected" until a few days before.

What emerges from the TV report, is that the active ingredients that are used by pharmaceutical companies worldwide come from laboratories that are somewhat lacking in hygienic-sanitary conditions and apparently have no requirements to guarantee the absence of contamination and, consequently, the safety of products that are then sold at bargain prices to the companies that hold the end product marketing authorizations.

Does all this make anyone 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 everyday drugs and NONE of the relevant bodies had noticed it, before a German "team of independent experts" (we learn from Report) published the evidence???

Note: to perform verifications, this team of experts used the same instruments and tools used in some of the analyzes commissioned by Corvelva on vaccine vials (mass spectrometry), instruments defined here as cutting-edge - while according to AIFA our analysis have no value.

Let's move on and see what's interesting about AIFA's reliability by watching this TV service.

The CEO of AIFA, Luca Li Bassi, has been interviewed and his words "season" the television service in several passages; hence we learn that:

- AIFA carries out about 250 inspections a year at the pharmaceutical companies; urged by the journalist who asks "Do the inspected companies know that you are coming to inspect them?" and "Out of 10 inspections, how many are surprise audits and how many are announced?" the response of the CEO of the Authority is that "honestly, most are announced". Starting from this assumption, how the effective efficacy of these inspections could be secured, appears a mystery.

- Li Bassi says as well that "The finished product is tested by companies", "company tests are carried out according to methods" and the journalist informs us that in 2017, out of 7,000 drugs on the market, AIFA just checked 78 lots .... What guarantees can come from these small independent checks? How can you think, for such delicate issues that concern billionaire affairs, to trust the tests carried out by pharmaceutical companies, the same ones that should be subject to control???

Under investigation by the Court of Auditors

Here follows another interesting point from current news:

“AIFA executives under investigation by the Court of Auditors, for a loss of revenue of 200 million euros”, so is written in a very recent article pubblished by the nwespaper Quotidiano Sanità, that you can read here.

The investigations - we read - allowed to ascertain that, despite comparative studies had demonstrated the substantial therapeutic equivalence, in terms of efficiency and safety, of the drugs AVASTIN and LUCENTIS, the first was not included among the products reimbursable by the National Health Service until 2014 and a series of unjustified limitations were subsequently imposed on its use at least until 2017, causing a significant increase in expenditure for the State”

“The increase in costs - the finance police specifies - was calculated on the basis of the price difference between the two drugs, from 600 to 730 euros per single dose, in relation to the total number of treatments that have been carried out with the more expensive LUCENTIS. The people under investigation, which at the time were in charge for the evaluation, both from a technical-scientific and an economic-financial point of view, of the inclusion of drugs in the list of those reimbursable by the National Health Service, now have 60 days to provide their defensive version to the magistrates of the Court of Auditors”.

“With reference to the marketing of AVASTIN and LUCENTIS, in 2014 the Italian Antitrust Authority had already fined the pharmaceutical companies of over 180 million euros for a competition-restricting agreement, in which they had invented an artificial differentiation of the products by showing the former as more dangerous than the latter, thus conditioning the choices of doctors and health services ".

What about vaccines?

As far as biological medicines are concerned, in particular vaccines, that in Italy were made compulsory for pediatric population by the law 119/2017, we can observe that the obsessive mediatic campaign aimed at showing them as “very safe and very efficient” can count hundreds if not thousands of articles on both paper and online magazines; every effort seems to be aimed at persuading Italian people that such drugs are absolutely safe, efficient and unique means of prevention against several diseases. Unfortunately the rare programmes of active vaccine vigilance show a very different scenario, so much that – if we want to grant them good faith – one wonders why such programmes are not regularly implemented and prepared for all recommended vaccines…maybe they are too expensive, but given the increase in the price of vaccines since the so called “Lorenzin law”, money doesn't seem to be a problem, moreover given the fact that control and research is delegated to pharmaceutical companies, why should not we ask for a donation for a serious and independent pharmacovigilance carried out by the Italian State? It is just a suggestion, just an idea. The latest available report on active pharmacovigilance is that of Puglia Region on MMRV vaccine (published in 2018) and it reported serious adverse reactions on 4 out of 100 children!

However, the latest statement on the subject made by Aifa concerns the possible presence of latex, not inside vaccines – as they specify in a note – but in primary packaging! Again, we are not talking about independent analyses of vaccines that would have led to an alarm, as we can read: “AIFA has nevertheless considered it appropriate to contact all the companies that hold the marketing authorization for the influenza vaccines in Italy, asking to certify, where not specified in the Summary of Product Characteristics (SPC) and in the Information Leaflet, the presence of latex in the components of primary packaging."

And since the articles published on various newspapers gave cause for misunderstanding, they decided to specify that “The notice published by AIFA concerns only the packaging of influenza vaccines in order to protect those who are allergic to this substance. This is to provide even allergy sufferers with an adequate vaccination by informing them about latex-free products. No contamination is therefore in the flu vaccines.”

But one question continues to lack concrete answers: where are the "batch by batch” controls and their results, the "independent analyses" carried out. Are there any? Can we see them? Can we have evidence of it?

Why, after declaring that the analyses commissioned and paid for out of one’s own pocket by an association of Italian citizens "do not provide useful data for a scientific evaluation" since "the methods of analysis used to verify the quality of the vaccines and the presence of any contaminants must be certified and compliant with the procedures and requirements shared at European and international level on the basis of the available scientific knowledge" and again that "the authorities in charge carry out checks throughout the production cycle of the vaccine. Furthermore, before distribution on the market, each individual batch is subjected to a further double check carried out, independently, both by the manufacturing company and by an international network of accredited laboratories" these results, or at least the data that would deny what has been published (and reported to the Public Prosecutor of to the Republic with - of course - original and certified laboratory data) by the association, are not made available to taxpayers (and recipients of an obligation)? In reality they did nothing more than these public replies but failed to show any excerpt of analysis in dispute to what we have reported, and did not even mention numbers or dates of the controls carried out, in order to give at least some substance to their words. We would like to stress, however, that the latest reports published by Corvelva contain the results validated by means of control standards and interlaboratory confirmations, we are thus dealing with citizens who are already pursuing in-depth studies, of their own money, before the silence of the institutions that should guarantee the safety of these products, especially, I point out again, when they claim to administer these products compulsorily and in the pediatric range.

In light of all the above, Aifa’s work leaves us perplexed as well as the attitude of closure and blame that the institutions hold before a part of concerned citizenship that only asks for clear answers and complete with verifiable data.

*translated by Chiara Remedia

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AIFA

Aifa: Reflections on the functions and works of the Italian Drug Agency (AIFA)

Nitrosamine Alarm

Under investigation by the Court of Auditors

What about vaccines?

In light of all the above, Aifa’s work leaves us perplexed as well as the attitude of closure and blame that the institutions hold before a part of concerned citizenship that only asks for clear answers and complete with verifiable data.

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