Global Insight Perspective | |
Significance | The authorities in Argentina are investigating a possible link between 14 deaths among children immunised with U.K. firm GlaxoSmithKline (GSK)'s vaccine Synflorix. |
Implications | An independent board monitoring participants' safety has now recommended that trials with Synflorix be temporarily suspended. |
Outlook | The allegations are serious, and could have further implications given that GSK is testing the vaccine in three Latin American countries. |
GSK in the Firing Line
Argentina's Food and Drug Administration is exploring an alleged link between the deaths of 14 children and U.K. pharma giant GlaxoSmithKline (GSK)'s experimental pneumococcal vaccine Synflorix, administered to the children as part of a clinical trial, reports AP. An agency official has confirmed the investigation after having received complaints about irregularities in the recruitment of patients for the drug trial. On 31July the Argentine agency asked for recruitment to be suspended. A total of 19,000 babies have received at least one dose of this vaccine. The Synflorix vaccine is aimed at fighting pneumococcal diseases, including pneumonia and ear infections.
A spokesperson for GSK, Sarah Alspach, has denied the allegations, saying that the deaths are not attributable to the vaccine. Alspach added: "Safety is our primary concern, always, with the development of any new treatment." GSK is testing Synflorix across three Latin American countries, including Argentina, Chile, and Panama. An independent board monitoring participants' safety has recommended that all three Latin American trials be suspended.
Ana Maria Marchese, the head of the health professionals labour association in Argentina's northern province of Santiago del Estero, criticised GSK's patient recruitment protocols: "They didn't explain to the parents that this was an experimental vaccine, and a lot of the parents who signed consent forms were illiterate." Marchese confirmed that seven of the 14 children came from the province of Santiago del Estero.
The province's local Health Minister, Franklin Moyano, has announced that the province is conducting a separate inquiry into the deaths of the seven children: "While legal authorities investigate, we're in an observation phase to see if everything happened as expected, or if there were deviations that caused damage, in this case the death of seven kids," he said.
Outlook and Implications
The implications of the latest allegations against the U.K. heavyweight bear a resemblance to the Russian Volgograd clinical trial where GSK vaccines Varilrix (chickenpox), Priorix-Tetra (chickenpox and measles-mumps-rubella; MMR), and Priorix (MMR) were tested on 100 babies aged 1-2 years in Volgograd. In this case, preliminary investigations found that GSK itself was not responsible for the adverse neurological events noted in some of the babies, a position the company continues to maintain (see Russia: 5 March 2007: GSK Vaccines in Spotlight as Russian Court Investigates Clinic Accused of Discrepancies in Paediatric Clinical Trials).
Although it is too early to know what the outcome of the Argentine investigation will be, the allegations are certainly very damaging for GSK, especially at a time when the company is trying to market Synflorix as a product with an edge over its main competitor, U.S. Wyeth's blockbuster vaccine Prevnar. Wyeth is currently developing an improved version of its blockbuster vaccine, Prevnar 13, which is undergoing Phase III clinical trials.
U.S. company Pfizer's 1996 clinical testing of meningitis drug Trovan (trovafloxacin) in Nigeria's Kano state earned the drug giant a civil action in a U.S. District Court and an ongoing dispute with the families of the Nigerian children alleged to have been killed or harmed by the company's clinical testing of an antibiotic. In April 2008, Pfizer was still trying to negotiate an out-of court settlement in the Trovan case over the alleged misconduct of the clinical trials (see Nigeria: 29 April 2008: Pharmaceutical Giant and Northern Nigerian State Resume Out-of-Court Settlement Talks).
The regulation of clinical trials in the developing world, including in Latin America, has come under the spotlight and this case may produce tighter regulation of clinical trials procedures, as was the case in Russia following the Volgograd clinical trial (see Russia: 2 April 2007: Investigation into Volgograd Trial of GSK Vaccine Finds "Irregularities").