This is apparently Switzerland's leading investigative Journalist Magazine
http://www.beobachter.ch/justiz/artikel/novartis_medikamentenversuche-an-obdachlosen/
google translator makes it kind of half understandable, but I do not understand it all exactly. Also it seems that the events were about 8 or 9 years ago
"Grzegorz S. * was 48 and lived temporarily in the homeless place of the city Grudziadz, three autostags north-west of Warsaw. At the beginning of 2007, a roommate took him to the inconspicuous clinic of the medical couple S. *. The roommate, a drug addict, knew a nurse at the clinic and knew that they could make some money there.
Grzegorz S. came to the office on the first floor of the uninviting building, in the middle of a residential settlement. One nurse picked up the personal details, a second one put S. an injection, a third paid him ten zloty - about four francs. Finished. They gave him a booklet and a thermometer, which he had to measure regularly and record.
Ten days later, he had to return the book, and the procedure repeated.
The homeless people from the home came to the clinic in those weeks, calling themselves "Good Medical Practice" ("Dobra Praktyka Lekarska"). With Grzegorz S., 21 homeless people are record-entry who were able to put injections - and had no idea that they were taking part in a drug trial.
From a test «nothing known»
The fact that they collected money for a "flu vaccination" did not make the homeless suspicious. Again and again they received clothes or small money from charity organizations. "A few zloty for cigarettes are always worth it. This was the decoy, "said Grzegorz S. of the Swiss human rights organization Public Eye, formerly Berne. She reconstructed the case in the last two years. "Several homeless people agreed that they were being vaccinated against the seasonal flu," says Public Eye's Alice Kohli. They were told nothing about a clinical trial.
Grzegorz S. says: "I have never agreed to be experimental rabbits. If I had known what the vaccinations were, I would not have participated. "The nurses were not interested in whether the participants were ill or drunk. "They simply wanted to vaccinate as many as possible." Once he was even offered five zlotys when he passed another person who was vaccinated.
Apparently, there were inconsistencies in several test centers in Poland. In June 2008, Novartis therefore withdrew the application for authorization for Aflunov. This was justified by the additional data required for the approval. However, in the "Assessment Report" published by the European Medicines Agency, it sounds somewhat different: the Committee on Medicinal Products has carried out so-called Good Clinical Practice Inspections at several test centers in Poland. The data from four test centers were excluded from the study, they did not meet the requirements. Aflunov was tested in Poland in 23 hospitals.
Good Clinical Practice is the internationally recognized guideline for the ethical, scientific and operational standards for all research activities in humans. It is the basis for the relevant laws throughout Europe, such as the Swiss Human Research Act. The central element of these laws is the protection of humans in clinical trials. One requirement is that volunteers participate voluntarily, have been informed about the tests and have given their consent in writing.
For Novartis, Aflunov was not a big deal. At the beginning of 2015, the Group sold the vaccine division to GlaxoSmithKline, but without the influenza vaccine field. This went to the Australian biotechnology company CSL in July 2015.
Aflunov was approved in the EU 2010, but not in Switzerland. Whether Novartis has ever applied for authorization in Switzerland or whether an application for authorization is pending, the Swissmedic medicine control authority does not want to say.
"It can not be that pharmacists treat the subjects of their clinical trials as second-class people and are making huge profits at their expense."
Philip Stolkin, lawyer of Grzegorz S. *
Novartis declares, on request, that there is no knowledge of a compensation claim. The Pharmac group emphasizes: "All Novartis clinical trials follow the ethical values laid down in the Helsinki Declaration and the Good Clinical Practice."
Grzegorz S. 'Philip Stolkin, a lawyer, says:' Novartis was the sponsor and sponsor of the clinical trial, and is therefore responsible for it. 'It is based on the Human Research Law, which is laid down in the clinical trial:' The sponsor and the test person of a clinical trial Clinical trials have to ensure scientific quality. "Stolkin:" Pharmacists may not be able to treat the subjects of their clinical trials as second-class people and make huge profits at their expense. "
