$6,643 per baby…or in the GSK project costing sheet
— a rounding error
Judge Marcelo Aguinsky has fined GlaxoSmithKline Argentina Laboratories 400,000 pesos ($93,000 USD) following a report issued by Argentina’s National Administration of Medicine, Food and Technology for GSK’s illegal lab trials of the vaccine Synflorix, conducted between 2007 and 2008 in which 14 babies died.
The charges included experimenting with human beings and 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. Pediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals, and was working at the Eva Perón children’s public hospital in Santiago del Estero when the studies were being conducted, said 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.”
“Laboratories can’t experiment in Europe or the United States, so they come to do it in third-world countries.”
Likewise, Marchese, explained the modus operandi: “Once a picked patient arrived, it would automatically disappear to be taken somewhere else in order to be treated by those doctors specially recruited by GSK. These kind of practices are not legal and occurred without any type of state control, plus they don’t comply with minimum ethical requirements.”
Marchese also remembered that “laboratory trials on human beings are not legalized in Argentina.” Furthermore, the pediatrician explained that “it is also known that in various particular cases, the doctors who had conducted the trials did not answer the calls made by the worried parents after witnessing their babies’ reactions to the vaccines.” According to Marchese, “there already exist very good vaccines for the same diseases, but we all know how laboratories work, they only care for their own business.”
Doctor Marchese appealed to Santiago del Estero Governor, Gerardo Zamora, who “never ever came out to comment on the case, and same happened with national deputies and senators that didn’t even bother into discussing a hot topic that was echoed worldwide. I’m also ashamed of the scientific community that also kept its mouth shut.” Julieta Ovejero, great aunt of one of the six babies who died in Santiago del Estero, said that “A lot of people wanted to leave the protocol but they weren’t allowed; they forced them to continue under the threat that if they leave they won’t receive any other vaccine.”
During 2008, the vaccine trial was still ongoing despite the reports issued by FESPROSA, and those in charge of the study told reporters that the procedures were being carried out in a lawful manner. On the contrary, the ruling states that the laboratory as well the involved doctors broke all legal requirements for conducting clinical tests on babies. Surprisingly, during same year pediatrician Enrique Smith, one of the lead investigators told reporters: “Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria.”
In Santiago del Estero, one of the country’s poorest provinces, the trials were authorized when Enrique’s brother, Juan Carlos Smith, was provincial health minister. According to FESPROSA, “the laboratory paid $8,000 pesos for each child included in the study, but none (of that money) remained in the province that lends the public facilities and the health personnel for the private research.” The case brings to light questions about how big drugmakers, looking for lower costs and readily available patients, conduct clinical trials in emerging markets.
India Has Taken Note
The issue has caused a stir India, for instance, where some 1,700 people who participated in trials died between 2007 and 2010, according to the drug regulatory agency, although no autopsies were performed to determine the causes of the deaths. In 2010, 22 families of the deceased were compensated by drugmakers, ranging from $2,000 to $20,000. Last year, trials generated business worth $300 million in India, the paper writes, citing data from the Confederation of Indian Industry, but saves drugmakers nearly 40 percent of the total cost of drug development.
“India is emerging as a hub for drug trials, and Indian patients are like guinea pigs.”
— C.M. Gulhati, editor of the Monthly Index of Medical Specialities Journal
Gulhati told the Washington Post, “The ethical review panels are bogus. The drug control authority approves almost all the trial applications without rigorous scrutiny. And poor, unsuspecting patients get duped, while doctors and hospitals earn money.”
Last year, two people working as brokers for an unnamed Indian drugmaker were arrested for allegedly recruiting poor and illiterate women from a rural section of India as guinea pigs in unauthorized clinical trials for a breast cancer drug. As many as 20 women, who were mostly farm workers and daily wagers, developed acute joint pains, swelling in arms and throat infections.
In response to the ongoing, and increasing, outrage, the Association of Clinical Research Organizations issued a white paper in 2009 arguing that overseas trials speed needed drug development; oversight is increasing in a growing number of countries and the influx of trial work ultimately raises standards and experience levels for medical personnel in those countries targeted for trials.
GSK plans to appeal Judge Marcelo Aguinsky’s decision, and stressed that the decision relates to the clinical trial process and not the safety of Synflorix; noting that the vaccine has since been approved to protect kids from strains of streptococcus pneumoniae that can cause meningitis, pneumonia and ear infections.
…and, “In a separate, and unrelated incident”, as the Monty Python’s Flying Circus announcer used to say…Andrew Witty, CEO of Vaccine Maker GlaxoSmithKline was just awarded a knighthood by the Queen of England ‘for services to the economy and the UK pharmaceutical industry.’ GlaxoSmithKline is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom. It is the world’s third-largest pharmaceutical company measured by revenues after Johnson & Johnson and Pfizer.
Buenos Aires Herald: GSK lab fined over vaccine tests that killed 14 babies
The Washington Post: India’s spike in drug trials raises questions
Additional Background: Pharmalot