Reports that 21 homeless people died in Poland after unknowingly participating in medical trials of a bird flu vaccine are unlikely to damage the country’s thriving clinical trial market.
Three doctors and six nurses from Grudziadz are facing criminal prosecution for allegedly misleading trial participants, paid £1-2 for testing what they thought was a conventional flu vaccine but was in fact a vaccine against the deadly bird flu virus H5N1.
A spokesperson from Novartis Vaccines, the company that commissioned the trials, said the firm was a victim of fraudulent behaviour. Moreover, media reports are erroneous because they infer the deaths were related to administration of the H5N1 vaccine, which was tested on 3500 other people without any deaths, said the spokesperson.
Around 110 companies – mostly international – conduct clinical trials in Poland. In 2007, the market for phase I-IV clinical trials and bioequivalence tests was nearly PLN630m (€167m), according to consultancy firm PMR.
Monika Stefanczyk, senior pharmaceutical market analyst at PMR, thinks the recent deaths are unlikely to impact this growing market.
Poland offers a large population, highly qualified staff, and a good infrastructure. Moreover, recruitment is relatively easy because the state’s pro-generic refund policy means that patients who suffer from serious diseases cannot easily access innovative therapies.
PMR expects the Polish clinical research market to be worth PLN 800m (€212m) by 2010 – but only if the Health Ministry relaxes the currently lengthy and complicated application requirements.
Polish law requires patients to consent to and understand the risks of a trial. However, as elsewhere, it is difficult for authorities to check if patients really understand the risks, says Stefanczyk.
‘If some bureaucratic procedures are relaxed, there would be more time to focus on patients’ safety,’ she says.
Meanwhile, experts remain concerned about a looming bird flu outbreak and are urging the vaccine R&D community not to become complacent (Nature 2008, 545, 160; 162).