Combacte is a model project in two different ways. It was one of the few IMI initiatives that Michel Goldman, who served as head of the Innovative Medicines Initiative (IMI) until the end of 2014, liked to highlight during presentations. With a total budget of over €250 million, it is one of the largest IMI projects. In November, at a meeting with pharmaceutical industry executives in Brussels, Goldman described how Combacte provides the answer to an "enormous public need."
The Combacte project is intended to speed up the development of new antibiotics that can be used to treat the increasing number of patients with dangerously drug-resistant bacteria. The project's core element is the creation of a Europe-wide network of hospitals where new antibiotics will be able to be tested on patients.
Unethical Study Design?
But Combacte is also the IMI project that has created the greatest recent uproar. The Milan-based Mario Negri Institute for Pharmacological Research served as one of the academic partners, but when a dispute developed in 2013 with project coordinator Glaxo-Smith-Kline (GSK), the Italians left the project. They then published an article in the British Medical Journal about the endeavor titled, "A Failed Attempt at Collaboration."
The dispute revolves around access to data from a clinical study that was meant to test an auspicious GSK-developed antibiotic. "The project is actually promising," says Mario Negrio Institute Directo Silvio Garattini, "but the study design that GSK wanted to implement was unethical."
"We were supposed to test an antibiotic on patients without getting access to the data from other hospitals afterwards," Garattini says. "We insisted that, as clinical researchers, we had the right and the duty to see the data and to contribute to analyzing it. In the interest of the patients, an independent review must be conducted by clinical researchers."
Officials at GSK claim the Mario Negri Insitute could have requested the data. "But they did not agree with the idea that we should first be allowed to evaluate the request," a GSK official says. "In order to avoid conflicts of interest in the process, we decided that a committee should handle such requests. Despite this, the Mario Negri Institute no longer wanted to participate in the project."
Putting America First?
Researchers were upset by a further point. The GSK antibiotic had been designed to combat a strain of the resistant MRSA bacteria that is rarely seen in Europe, where other highly dangerous multi-drug resistant bacteria like carbapenamase-producing Enterobacteriaceae (CPE) are far more prevalent. But GSK wanted to conduct its testing on the MRSA bacteria because it remains a major problem in the United States, and a new antibiotic in that market could be lucrative for GSK.
GSK defended its study with the experimental MRSA antibiotic. "Drug resistance is a global problem that is not limited to one continent," the company stated. "We are working both in Europe and America to speed up the development of antibiotics," a spokesperson said.
After two years of preparations, GSK ultimately didn't test the experimental antibiotic -- but not because of the researchers' complaints. The medicine, it turned out, caused testicular cancer in rats.