Dec 14, 2012

Towards open data: When Glaxo plead guilty...

The largest health care fraud settlement occurred this past July, with GlaxoSmithKline pleading guilty to the criminal charges brought by the US Justice Department. GSK will pay $1 billion in criminal fines and forfeitures as well as $2 billion in civil damages related to other drugs. The drug company also agreed to be monitored by government regulators for five years.

The crimes in question are severe -- marketing and targeting the drug Paxil to under 18s when only approved for adults; and pushing the drug Wellbutrin for uses it was not approved for, such as weight loss. Other cases of misconducted were highlighted during the well publicized case. Including neglecting to provide safety data to the FDA on the drug Avandia. A drug whose side effects prove lethal.

According to Reuters, guilty pleas in cases of alleged corporate misconduct are exceedingly rare. Perhaps this mea culpa on their part signals a change in mentality over at Big Pharma.

That was July, however. In what seems like a recent turn around, GSK have pushed for more inhouse openness when it comes to the sharing their data. The strive to become “open and transparent” is one adopted by many strands of researchers, politicians and guardians of data; but is definitely one that hasn’t found traction within the laboratories of Big Pharma.

Forbes magazine called it “an unprecedented move that could signal dramatic changes in the drug industry” when it was announced by Andrew Witty, GSK Chief Executive, in London. He promised to make clinical trial data freely available to independent researchers. Allowing the scientific community to build on that detailed data. Perhaps this should come as no big surprise, as the British drugmaker had also previously made its chemical libraries available to researchers working on drugs against specific diseases such as tuberculosis and malaria.

“Because of our unique role, we recognize that society holds us to higher standards than for other industries. This is how it should be. Over the last four or so years we at GSK have been working hard to be more open and transparent. As I have shown these new approaches are helping to provide new solutions for serious global health issues. They will also help build society’s trust.”

Whether or not the pledge for openness is a knee-jerk reaction to recent scandals and the massive US fine probably just depends on your point of view on Big Pharma.

Patrick Vallance, the senior vice president in charge of drug research at Glaxo remarked, “We think that it’s the right thing to do for patients, we think it’s the right thing to do for understanding our medicines. I think if you volunteered to be in a clinical trial, your legitimate expectation is that your data will be used to insure that future generations of patients get the maximal advantage.”

In the end, the hope is this gesture will be adopted by other drug companies across the industry. An industry that could do with both the good will and press this gesture evokes, as well as the wealth of information to be gathered from it.

Written by Dr. Charles Ebikeme for The All Results Journals.

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