2014-08-22

Illegal testing of Novartis bird flu vaccines in Poland in 2007

1.2.4

Since the reports about Novartis drugs tested on Polish patients without their informed consent start to disappear from public news archives as the years go by (see a similar case of such news disapearing from German Web servers here or here), I decided to update the Wikipedia Novartis article with this section:

Illegal testing of Novartis flu vaccine in Poland

In 2007 in Grudziądz, Poland, the Focetria drug - a new A/H1N1 bird flu vaccine being introduced by Novartis, was tested by Polish doctors on homeless (for money) or on unsuspecting patients, without informed consent. 350 people received this vaccine[69][70][71][72]. Three doctors and six nurses were charged[73] and in 2009 the judge extended the proceedings[74].
Court case against the doctors,
wearing wigs and sunglasses



As expected, it was deleted by other Wikipedians very soon.

I was then asked for an update about this affair.

I have thus duly checked the news and here is the case itself with the subsequent developments.


Firstly, it's worth to note that some newspapers reported it to be a "tip of the iceberg", that is the only such case which went public, implying that this Novartis drug was illegally tested by other doctors without informed consent.

Novartis clinical trials illegal? [...] The “Dobra Praktyka Lekarska” clinic in Grudziadz was one of the 16 Polish centres engaged in the third phase of clinical trails of the Fluad-H5N1 bird flu vaccine, produced by Novartis. It was a part of a clinical trial covering 4,400 participants in Poland, the Czech Republic and Lithuania. [...] The case is under investigation, but the Office for the Registration of Medicinal Products, Medical Devices and Biocides (URPL), which is responsible for monitoring such cases, claims that the situation may be repeated in the future, as the office has only one inspector controlling clinical trails, and no money to create more posts.
[Ceepharma]


The tests were not authorized by the Polish Ministry of Health or other relevant Polish health authorities:

"Informujemy, że ani Ministerstwo Zdrowia ani Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych nie wydały zgody żadnej firmie farmaceutycznej na prowadzenie badań klinicznych nad szczepionką przeciw tzw. świńskiej grypie (AH1N1). Żadne takie badania nie były i nie są prowadzone"
[source]



For the historical record, the doctors and nurses who were prosecuted (but not charged yet, as of August 2014) were working for:

Grudziądzkie Centrum Pomocy Dobra Praktyka Lekarska
ul. Chełmińska  74
86-300 Grudziądz
Poland
and their names are likely listed here:
Doctors' new clinic
and here:
Doctors' another new clinic

This is what Polish Minister of Health said about them back then:
Poland's health minister, Ewa Kopacz, has said that the doctors and nurses involved should not return to their profession: "It is in the interests of all doctors that those who are responsible for this are punished," the minister added.

As of 2014, the court proceeding is still ongoing, due to the lawyers trying to hush it up.

Here are some archived sources, before they disappear due to data rot or another inane EU court ruling:

In English:
  • Flutrackers translation of a Polish article (the Polish original is gone by now)

In Polish:

History of the case:
2007, February: First Novartis flu vaccine tests in Poland started
2007, February and March: Illegal tests of Novartis vaccines administered in Grudziądz
2007, November and December: A court case against the Grudziądz doctors and nurses (not Novartis) was initiated
2009: Third session of the court
2013, November: the court case was still ongoing [source: W Polityce]

Please contact me below for more info, if needed.

Update 1:
It's nice to learn, dear Swiss Internauts, that you immediately visited my humble blog once I posted this very article:

Congrats: rapid keyword filtering in action!

2 comments:

  1. Please contact me, I'm a swiss journalist and would like to cover this story
    maria.roselli@rsi.ch

    ReplyDelete
  2. Please contact me, I'm a swiss journalist and would like to cover this story
    maria.roselli@rsi.ch

    ReplyDelete