Originally published October 2 2013
GSK accused of secretive clinical trials of antibiotics, bizarre demands for control over results
by Jonathan Benson, staff writer
(NaturalNews) An Italian research institute has severed collaborative ties with British drug giant GlaxoSmithKline (GSK) following a major dispute over who should have access to a series of clinical trial data on antibiotic treatments. As reported by Chemistry World, GSK refused to allow raw data from an allegedly "open access" clinical trial on new antibiotics to be viewed by anyone other than a select group of corporate insiders and insisted upon retaining total and perpetual control over the final results of the trial, even though the project is largely being funded by taxpayers.
In a feature paper recently published by the peer-reviewed British Medical Journal, Silvio Garattini and his colleagues from the Mario Negri Institute for Pharmacological Research (MNIPR) blasted GSK for failing to cooperate with reasonable collaborative research guidelines. What was meant to be a fully transparent public-private partnership between MNIPR and GSK, the purpose of which was to speed up development of innovative new medicines, essentially became a freak show with GSK as the ringleader.
According to the paper, MNIPR researchers were astounded when GSK came in and forcefully demanded that its own research protocols take precedence over more reliable and unbiased ones. The drug giant brought in its own company-authored project agreement as well, with dozens of pages of rules and conditions that were not collaborative in nature and that would have given the company complete control over the trial.
Garattini is quoted as saying that GSK basically insisted that "it alone" would be the only entity with access to the raw data from the trial, as well as have sole control over how it would be used. In other words, GSK pretended to support an open access, collaborative trial on new antibiotics on the world stage in order to receive funding, but in the laboratory, the company quickly assumed the role of a scientific dictator calling all the shots and demanding compliance.
"Although we fully support the idea of further collaboration with industry, on this occasion the cooperation was not quite what we had hoped for," wrote the authors about the experience. "GSK set down the protocol for the clinical research in the partnership, and when we questioned some of the company's methodological choices -- such as the comparator drug and sample size -- it became clear that these were not open for discussion."
GSK attempts to hijack science using taxpayer dollars
What makes GSK's offenses even more nefarious is the fact that the project was part of the European Union-based Innovative Medicines Initiative, which receives government funding. By trying to hijack the trial for its own special interests, GSK essentially tried to defraud both the scientific method and taxpayers at large, who helped foot a substantial portion of the bill for GSK's ghoulish, and yet hardly surprising, behavior.
This would hardly be the first time that GSK has taken government money for research projects that it would later try to hijack. An announcement issued by GSK back in May, for instance, indicates that the company received a $200 million grant from the U.S. government to conduct similar collaborative research on new drugs to fight antibiotic resistance. GSK is also busy partnering with governments and non-profit groups in Africa, its next major market.
"GSK wanted to retain the right to permit or refuse access to the patient outcome data and to give written approval for any independent publication of the data generated by the public-private partnership," add the authors, as quoted by Pharmalot. "That meant we would have had to ask GSK's permission to access the data from our own trial and that GSK reserved the right to block publication of our analysis of that data at any time after the study was completed."
Sources for this article include:
http://www.rsc.org
http://www.gsk.com
http://www.pharmalive.com
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