In Poland, deaths after bird flu vaccine trial raise questions (and possibly criminal charges)

Reports coming out of Poland have potentially linked a trial of a new bird flu vaccine to the deaths of 21 homeless people:

Three Polish doctors and six nurses are facing criminal prosecution after a number of homeless people died following medical trials for a vaccine to the H5N1 bird-flu virus.

The medical staff, from the northern town of Grudziadz, are being investigated over medical trials on as many as 350 homeless and poor people last year, which prosecutors say involved an untried vaccine to the highly-contagious virus.

Authorities claim that the alleged victims received £1-2 to be tested with what they thought was a conventional flu vaccine but, according to investigators, was actually an anti bird-flu drug.

While the deaths may not be directly attributable to the vaccine, these kinds of news reports are exactly the thing that makes people shy away from participating in clinical trials, even when that would be the best available treatment for a particular disease. For example, many people do not know that for cancer clinical trials, participants either receive the current “gold standard” of treatment or that “gold standard” plus a new agent. Many people think they are at risk of being “guinea pigs” who receive no treatment.

When it comes to testing drugs, especially in the initial phases, I don’t think it’s ever appropriate to test exclusively (or mostly) on vulnerable populations. We find it highly unethical, for example, to test drugs on prison inmates, even if they were to be paid to participate in the testing. Testing drugs on prisoners, the homeless, those who are developmentally disabled, or those who are illiterate brings into question whether or not these individuals can give an informed consent for their participation.

Whether or not these 21 deaths are related to the H5N1 vaccine trial or not, this report calls into question the behavior of the investigators on three counts: first, because they may not have disclosed that the test was for H5N1 (avian) flu and not the “conventional” flu; second, because they received $2 to $4 to participate (a paltry amount); and third, because the participants were homeless and most likely not able to give a full and considered informed consent to participate.