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| Glaxo Pneumonia Vaccine Trial - 12 Babies Dead | ||
| Pharmalot Controversy Over A Glaxo Clinical Trial In Argentina September 23rd, 2008 By Ed Silverman  Maria Ester, 23, lives in a crumbling, one-room stucco cottage with her mother and daughter in Santiago del Estero, an Argentinean province northwest of Buenos Aires, according to ABC News. She had another daughter, but the 5-month-old died in May and had been one of more than 13,000 Argentinean children to participate in a Glaxo clinical trial begun last year. And Ester tells ABC News that if her infant hadn’t participated in the study Michaela would still be alive. “Protocol Compas” is the name of the study designed to test the efficacy of Synflorix, Glaxo’s experimental pediatric pneumonia vaccine, which can also ward off the bacteria that causes meningitis and ear infections. But at least 12 babies in the trial have died over the past year in Argentina, and critics say the study uses children from poor families, who are pressured into signing consent forms (back story). The suggestion is denied by Ricardo Ruttiman, Glaxo’s regional medical affairs and R&D director, who is responsible for “Protocol Compas” in Argentina. He tells ABC News participation is always voluntary and parents “are informed, clearly and in a language they can understand, by experienced medical investigators.” He adds they are informed of benefits, such as round-the-clock access to medical care and vaccinations against diseases, as well as risks, which he describes as few. But Ester says a nurse’s aide her that doctors at the Eva Peron Children’s Hospital wanted to give her infant a vaccine. Ester only gave in, she says, when the nurse’s aide allegedly threatened to go to the police and have her baby taken away. “I didn’t know if the doctors, the police, the system would take her away, but I was afraid,” she tells ABC News. She found herself signing a 12-page consent form she says she couldn’t really understand, and then allowed her infant to receive a first injection. Health-care professionals say holding clinical trials in regions with poor health-care systems can benefit everyone. Ruttiman points out that due to the high quality of care the children in the study receive, the infant mortality rate is significantly lower in those who participate in “Protocol Compas” than in those who do not, but he declined to comment on individual cases citing patient privacy. But Ana Maria Marchesse of Eva Peron Children’s Hospital is one of several Argentinean doctors who is highly critical of the study’s methodology. She heads up the Health Professionals’ Labor Association, a group of local doctors who alerted La Federacion de Profesionals de la Salud de la Republica Argentina (the Argentinean FDA) of their concerns about possible wrongdoing. “It’s impossible to say whether the 12 babies’ deaths are due to the vaccine or not, because half of the [total number of] children were given a placebo,” the pediatrician tells ABCNews. “But the way the study has been conducted is reprehensible.” Here’s the complete story… |
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