With thanks to Pharmalot 23.10.08 and ABC News 23.10.08:
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.
At least 12 babies who were part of a Glaxo clinical study to test the effectiveness of a vaccine against pneumonia have died over the past year in Argentina, reports TradingMarkets.com. And the study uses children from poor families, who are “pressured and forced into signing consent forms,” the Argentine Federation of Health Professionals, or Fesprosa, charged.
“This occurs without any type of state control” and “does not comply with minimum ethical requirements,” Fesprosa said, according to Argentine press reports cited by TradingMarkets. The vaccine trial is still ongoing despite denunciations, and those in charge of the study were cited by the Critica newspaper as saying that procedures are being carried out in a lawful manner.
Fesprosa’s Juan Carlos Palomares said that “in most cases, these are underprivileged individuals, many of them unable to read or write, who are pressured into including their children” in the trials. “The laboratory pays $8,000 for each child included in the study, but none (of that money) remains in the province that lends the public facilities and the health personnel for the private research.”
Since 2007, 15,000 children less than one year old from three Argentine provinces were enrolled. “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,” pediatrician Enrique Smith, one of the lead investigators, TradingMarkets reports. Glaxo maintains the death rate in the trial is the same as in other countries where the vaccine is being tested. (See the Glaxo statement below).
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 Argentine media.
However, Ana Maria Marchese, a pediatrician who works at the children’s hospital in the provincial capital where the studies are being conducted, argues that “because they can’t experiment in Europe or the United States, they come to do it in third-world countries.”
“A lot of people want to leave the protocol but aren’t allowed; they force them to continue under the threat that if they leave they won’t receive any other vaccine,” claimed Julieta Ovejero, a great aunt of one of the six babies who died in the province of Santiago del Estero.
A Glaxo spokeswoman send us this statement: Glaxo “has extensive experience in conducting clinical studies worldwide, including in Latin America. Safety is always our primary concern in the development of any new treatment or vaccine. All studies are conducted according to the highest ethical and scientific standards and in compliance with international standards of Good Clinical Practice (GCP).
“Since the beginning of the study, COMPAS is monitored by an Independent Data Monitoring Committee (IDMC) to oversee the safety aspects of the study and to help ensure that the highest ethical, safety and compliance standards are followed, including informed consent. Enrollment in the trial is on a voluntary basis and trial participants are free to withdraw at any time.
“The COMPAS study is designed to evaluate the protective efficacy against pneumonia and acute otitis media of a pediatric pneumococcal conjugate vaccine compared to active control vaccines.” Glaxo goes on to note that the vaccine is being tested in Europe, Asia, Africa and Latin America.
And Glaxo maintains that “the infant post-neonatal mortality rate of children participating in the COMPAS study does not exceed the post-neonatal mortality rate in the countries participating in the study.” The drugmaker adds that pneumonia is the worldwide leading cause of death from infectious disease and is also responsible for more than two million deaths every year in children below five years of age,” mostly in developing countries.
“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.”
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.
With thanks to ABC News 23.10.08:
Maria Ester, 23, lives in a crumbling, one-room stucco cottage with her mother and daughter in Santiago del Estero, an Argentine province northwest of Buenos Aires. Ester’s 5-year-old daughter and assorted neighborhood children crowd the room, and a sagging mattress that smells like it belongs to a young bed wetter is the only place for a visitor to sit down.
An adult might find the room oppressive. But from a child’s perspective, a benefit to living in a shanty is that no one really minds if you draw on the walls. Ester’s walls are colorfully scribbled.
Sharp-featured, with glossy hair and warm, brown skin, Ester’s small body is still plump with baby weight. She had another daughter, Michaela, but the 5-month-old died May 28.
Michaela had been one of more than 13,000 Argentine children to participate in a clinical study implemented a little more than a year ago by the London-based GlaxoSmithKline, the world’s second-largest drug manufacturer.
Streptococcus pneumoniae is a major cause of meningitis and pneumonia in children in Latin America. More than 12 million pneumonia episodes occur each year in this region in children under five and it is estimated that at least 50,000 children die each year of pneumonia in the region according to 2006 data from UNICEF.
Ester says 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, GSK’s experimental pediatric pneumonia vaccine, which can also ward off the bacteria that causes meningitis and ear infections. Synflorix is still in the preapproval stage.
GSK compares Synflorix with Wyeth’s hugely successful Prevnar vaccine, which has proved effective in the United States. Besides Argentina, trials are also being conducted in Panama, Chile and Colombia.