GLAXOSMITHKLINE, Britain's biggest drug firm, has been fined by an Argentine court over clinical trials of a pneumonia vaccine which was tested on thousands of babies from poor families.
The firm failed to get proper consent from the children’s parents before injecting Synflorix, one of its bestselling vaccines, according to a judge in Buenos Aires.
GSK was also criticised for keeping inadequate records of the children’s ages, medical histories and previous jabs.
Evidence from Argentina's medical regulator said that, in a few cases, scientists working for GSK relied on permission from under-age parents or illiterate grandparents, The Times reported.
GSK and two of the scientists who led the trial have been fined a total of one million pesos (€181,678).
Jorge Yabkowsky, president of the Argentine Federation of Health Professionals, told The Times: “These are people who depend entirely on the state apparatus and who are most often illiterate.
“They are vulnerable sections of society. They are unable to read any kind of consent form. GSK's recruitment of these people was absolutely unethical.”
The trial, known as Compas, involved 15,000 Argentine babies and 9,000 in Colombia and Panama.
The study began five years ago and is continuing. Such work is central to a strategy laid out by Andrew Witty, the chief executive of GSK, who has emphasised vaccines in developing countries as a commercial priority.
Mr Witty wants to diversify away from "white pills in Western markets", The Times reported.
GSK paid scientists carrying out the study for each baby signed up. Families were given no financial incentives.
A GSK spokesman said: “We conduct clinical trials to the same high standards, irrespective of where in the world they are run. This includes the requirement to obtain informed consent from participants. That is a fundamental principle of our behaviour and any deviation is unacceptable.
“In this case, we proactively alerted the authorities and implemented a corrective action plan. The Argentinian authorities agreed to continue with the study.”