By Ed Silverman // January 3rd, 2012 // 11:45 am
Following an investigation by the National Administration of Medicine, Food and Technology, the Argentine government has fined GlaxoSmithKline the equivalent of roughly $93,000 for its handling of vaccine trials several years ago in which 14 babies died. The probe found the drugmaker and two trial investigators failed to heed proper informed consent procedures, The Buenos Aires Herald reports.
The study, which was called Protocol Compas, ran in 2007 and 2008, and was designed to test the efficacy of Synflorix, which at the time was an experimental pediatric pneumonia vaccine used to ward off the bacteria that causes meningitis and ear infections. But critics chaged the study used children from poor families who visited public hospitals and were pressured into signing consent forms (back story).
“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,” according to Ana Marchese, a pediatrician who worked at one of the hospitals and reported the case to the Argentine Federation of Health Professionals. “Laboratories can’t experiment in Europe or the United States, so they come to do it in third-world countries.”
We have asked Glaxo for a reply and will update you accordingly. [UPDATE: A Glaxo spokeswoman sends us a statement which reads, in part: “It is important to note that the ANMAT’s ruling does not in any way question the safety of the study vaccine, Synflorix. The ANMAT’s ruling relates to the clinical trial process and not the vaccine. GSK respects the ANMAT’s decision but disagrees with the ruling and is therefore initiating an appeal against court proceedings. The Compas trial was completed in Argentina on June 30, 2011 in three provinces (Santiago del Estero, Mendoza and San Juan) and is now undergoing its closing phase.”]
The episode, which received substantial publicity more than three years ago, contributed to the ongoing debate over the veracity of clinical trials conducted overseas, where there are varying standards of regulatory oversight. The push for foreign trials comes as drugmakers look to lower costs and find new populations that are more willing to participate (see here and here).
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 not peformed to determine the causes of the deaths. In 2010, 22 families of the dead were compensated by drugmakers, ranging from $2,000 to $20,000, The Washington Post writes (read more here).
Last year, trials generated business worth $300 million in India, the paper writes, citing data from the Confederation of Indian Industry, but saves drugmakres 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, tells the 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 are mostly farm workers and daily wagers, have developed acute joint pains, swelling in arms and throat infections (back story).
In response to the ongoing ruckus, 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 (read here).