Argentinean court upholds fines against GSK and two doctors for malpractice during vaccine trialBMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e449 (Published 17 January 2012) Cite this as: BMJ 2012;344:e449
An Argentinean court has dismissed an appeal by the drug company GlaxoSmithKline (GSK) and upheld a fine of 400 000 pesos (£61 000; €73 000; $93 000) for failing to properly monitor a trial of the multivalent pneumococcal conjugate vaccine Synflorix.
The judge has also upheld fines against two local doctors of 300 000 pesos each. Miguel Tregnaghi, the main coordinator of the trial in Argentina, was fined for failing to comply with good practice in the development of a clinical trial, and Hector Abate, the main investigator in Mendoza, one of the three regions where the study took place, was fined for administrative irregularities during patient selection and the collection of informed consent.
The penalty, the maximum that can be applied under national regulations for serious misconduct and the highest ever relating to clinical trials in the country, was imposed in 2009 by the Argentinean National Administration of Drugs, Food and Medical Technology (ANMAT) after detecting irregularities in the recruitment of a few patients to the clinical otitis media and pneumonia study (COMPAS).
The fine has been upheld by a judge of the economic crime court, Marcelo Aguinsky, who rejected an appeal by GSK and the doctors. The main investigators in the other two provinces involved in the study, who were also fined initially, are still awaiting the resolution of their appeal.
As a result of the penalty the rules governing clinical trials in the country have been tightened.
There were 14 deaths among the 14 000 babies enrolled in the Argentinean arm of the study, which aimed to determine the efficacy of Synflorix in a high risk population, but GSK and ANMAT say that the vaccine was not responsible.
However, certain irregularities were detected by GSK and by ANMAT during the recruitment of a small number of infants in 2007 and 2008 in the poor rural provinces of Santiago del Estero, Mendoza, and San Juan. For example, a few parents whose children were admitted to the study were found not to understand the scientific terms used during the consent procedure.
“The company reported these findings to ANMAT and immediately put in place a corrective action plan,” said a GSK spokesperson.
When the first deaths were reported four years ago, Lorena Sequeira, mother of one of the infants who died, told the Spanish daily newspaper El País that when she went to vaccinate her daughter “a doctor told me I had to sign a paper and gave me 13 explanatory sheets, but at that moment she didn’t allow me to read them because there were many [other] mothers also waiting for the vaccine.”
She added, “She did not explain to me that it was a test, that the vaccine was not approved, or whether it had risks.”
Further recruitment to the study was immediately suspended, said ANMAT.
However, GSK insists that, after new policies were put in place, “ANMAT was comfortable to let the study continue as planned to conclusion.”
Ana Marchese, regional representative of the Argentine Union of Health Professionals and who is a paediatrician at the Eva Perón children’s hospital, reported several other irregularities. In an interview for the Buenos Aires Herald she complained that “in various cases the doctors who had conducted the trial did not answer calls from worried parents after witnessing their babies’ reactions to the vaccines.”
“If true, these events are shocking” and clash with the guidelines of the trial, said GSK. “We will be looking into this further,” the company added.
Dr Tregnaghi rejects the allegations.
The union also claims that doctors working in the public healthcare system were paid by GSK for each child they recruited and that they may have been involved in coercing some families to join the study.
“Any figures quoted for payments made to investigators per baby are completely erroneous, and the study simply did not work in that way,” said GSK.
Dr Tregnaghi, who is head of the Centre for Development of Advanced Projects in Pediatrics, a civil non-profit association running the local study, added that fewer “than half a dozen of mothers out of more than 13 000” complained. He criticised lawyers for the Union of Health Professionals for going into families’ homes “to spread terror” and urge them to sue GSK.
Dr Tregnaghi also considered the fine to be disproportionate to the “minor administrative irregularities” and the fact that “there was no injury or risk to the population’s health.”
In a statement José Brea Del Castillo, president of the Latin American Society of Paediatric Infectious Diseases, lent his support to the doctors involved in the study.
GSK and both doctors are appealing to the Supreme Court against the ruling.
Cite this as: BMJ 2012;344:e449