Buenos Aires Herald
February 3, 2012
By Javier Cardenal Taján
BuenosAiresHerald.com staff
GlaxoSmithKline Argentina Laboratories Company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for irregularities during lab vaccine trials conducted between 2007 and 2008 that allegedly killed 14 babies.
Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined with 300,000 pesos each for irregularities during the studies.
The charges included experimenting with human beings as well falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.
Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.
A total of seven babies died in Santiago del Estero; five in Mendoza; and two in San Juan.
Pediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals (FESPROSA in Spanish), and was working at the Eva Perón children’s public hospital in Santiago del Estero when the studies were being conducted, said this morning in conversations with Continental AM radio that “GSK Argentina set an protocol at the hospital, and recruited several doctors working there.”
“These doctors took advantage of many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”
The deaths of these babies is utterly tragic.
The doctors were charged with “irregularities”. The term should be “regularities” because in connection with clinical studies this type of behaviour is unfortunately a normal phenomenon.
There is widespread practice in manipulation of clinical studies. Clinical studies are related to greed, blatant lies, fixing of study safety statistics, hiding of information, bribery on many levels, threats and complete lack of ethics.
The whole issue of clinical trials is a disgrace. The protocols are written by the pharmaceutical industry who manipulate so that results are favourable for themselves.
Investigators are not required to register planned group and sub-group analyses. If a protocol is discontinued the results don’t have to be passed on to the regulatory authorities.
But why are trials stopped? Because “there are difficulties”. One “difficulty” may be because some patients die.
These are not clinical trials. They are cynical trials.