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 350 patients from the Grudziadz clinic, however, were convinced that they were being vaccinated against the “common” flu. Moreover, the homeless people engaged in the trial received money for their participation (PLN 5-30 (€1.4-8.3)), which is against the law, as payment for medicine testing is allowed only in first-phase clinical trials and only for healthy volunteers. As the patients were not registered, some homeless people took part in the trial more than once. 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.