In Europe also, vulnerable people are used for clinical trials, as in Poland where Novartis tested a vaccine against avian ’flu on homeless people without obtaining their consent. One participant in the clinical trial intends to file a complaint against the Basel-based company. This procedure could be a landmark event.

They gave him an injection and handed him a 20-złoty banknote – worth about 8 Swiss francs. Not a word more. No-one mentioned avian flu. He was just led to believe that it was an ordinary vaccine against seasonal flu. This is how Grzegorz S., today 58 years old, remembers the events of 2007 that took place in a clinic in the Polish town of Grudziadz, situated in the middle of nowhere between Warsaw and Danzig. Grzegorz was then a resident in a hostel for the homeless. Destitute, and tempted by the idea of earning a little bit of money, he decided to go to the clinic. If he had known that it was for a clinical trial, he wouldn’t have taken part, as he confided to Public Eye in 2016.

In February and March 2007, an experimental drug – the anti-flu treatment Aflunov (Fluad-H5N1) – was tested at Grudziadz on about 350 people. The series of trials V87P4 was intended to prove the efficacy of this pre-pandemic vaccine against the H5N1 virus, better known as “avian flu”. The illness was rampant in South-east Asia at the time, and represented enormous commercial potential for pharmaceutical companies. Fearing an epidemic, many governments wished to ensure adequate supplies of vaccine: this was a very profitable market, especially for the company that could obtain the authorisation to market a product that was effective again avian flu.

Indecent haste

It was therefore urgent to test the safety and efficacy of Aflunov. The research organisation mandated by Novartis to conduct the clinical trial in Poland was also aware of the urgency of the situation. As a result, the contracts were signed in haste in the clinic at Grudziadz, one of the 23 where the vaccine was tested in Poland, the Czech Republic and Lithuania. The medical team had required the nursing staff to find people willing to participate in the test as quickly as possible. Patients already at the clinic, members of their families and others they knew were vaccinated first. When it was no longer possible to find other people in their entourage, a well-known drug addict in the town was asked to recruit guinea-pigs in the Frère Albert homeless shelter. Sometimes, the nursing staff themselves signed the consent forms and, in certain cases, even took part of the fee that was due to be paid to those who participated in the trial.

Prison sentences and fines

It was by chance that the police became aware of the situation, following an affray between the residents of the home concerning the amount received for their participation.

According to the director of the home, about 20 residents died that year, which was significantly higher than normal. He does not know whether this was connected with the clinical trials, but he believes that it is possible that the administration of the vaccines could have had negative consequences for the residents. He therefore requested that the prosecution open an investigation. His request was denied on the grounds that a medical examination had proven that the vaccine was not harmful to health. The doctor responsible for the examination, cited by the prosecution, had been paid by Novartis.

Subsequently, the study in question was invalidated by the competent European authorities. However, a trial did actually take place. The prosecution initiated proceedings against the doctors, and the nurses working in the surgery, for falsification of documents and undue enrichment. In November 2014, they were fined and forbidden to practice. The public prosecutor considered that the sponsors of the study had suffered a loss. The surgery personnel had not respected the terms of the contract that linked them to Novartis and to its Polish sub-contractor. The latter even obtained a promise of compensation. As for the residents affected, they received no indemnity. The lawyers acting for the nursing staff are appealing.

In January 2017, just before the deadline for the limitation period for this case, the Appeal Court at Danzig rendered its judgment: six nurses and three doctors were declared guilty of falsification of documents and undue enrichment, and were given fines and suspended prison sentences.

© Mark Henley/Panos
Ethical standards were violated when a bird flu vaccine was tested on homeless people in Poland.

What responsibility lies with Novartis?

The Polish tribunal attributed all the responsibility for this affair to the clinic personnel. This was an astonishing decision since, on the one hand, the doctors and the nursing staff were subjected to severe pressure and, on the other hand, the related international directives stipulate that the sponsor of a clinical trial is responsible for its conduct. It is the responsibility of the sponsor to ensure that those people willing to take part in a clinical trial be adequately informed about its nature, and therefore able to give their informed consent.

In fact, the Polish tribunal even awarded compensation to the company that represented Novartis, on the grounds that it had suffered a loss from the clinic. The participants in the trial, in contrast, received nothing: no compensation for infringement of the individual’s rights; and no compensation for their resulting health problems.

Today, Grzegorz S. is claiming 50,000 Swiss francs in damages and interests from the Basel-based giant, and at least 50,000 Swiss francs representing the sharing of profits – Novartis having in the meantime sold its vaccines division for a high price. In order to delay the deadline for the limitation period, his Zurich-based lawyer has submitted a request for the prosecution of the group for an amount of five million Swiss francs. For the lawyer, it is clear that the sponsor must also take responsibility for the behaviour of those persons who support it in conducting the test – in this case, the organisation commissioned to undertake the research, the doctors and the nursing staff. This principle is enshrined in law in both Poland and Switzerland.

If the legal action is successful, the decision could affect tens of thousands of people who are currently participating in clinical trials for Novartis around the world. It is essential that the pharma giant accept its responsibilities, and in future take all necessary measures to guarantee the protection of people who participate in drugs testing.

Recent developments

Novartis refused an out-of-court settlement with Grzegorz S. during the attempt at conciliation that took place in July 2017 at a civil tribunal in Basel. The legal proceedings are continuing. Public Eye is not formally involved in the judicial part, but is following the case closely.