GSK hits back at 60 Minutes whistleblower interview
pharmafile | January 6, 2011 | News story | Manufacturing and Production | 60 Minutes, Avandamet, Bactroban, Cheryl Eckard, GSK, GlaxoSmithKline, Kytril, Paxil, manufacturing compliance
GlaxoSmithKline has responded to an edition of US current affairs show 60 Minutes centring on manufacturing problems at its now-closed manufacturing facility in Puerto Rico, saying that no patients were harmed by product made there.
The show featured an interview with GSK ‘whistleblower’ Cheryl Eckard, who claims she was the catalyst for an investigation into the plant in Cidra that ultimately led to the drugmaker receiving a $750 million fine for manufacturing adulterated medicines.
Describing the plant as “the worst thing I had run across in my career”, Eckard told 60 Minutes that water contaminated with bacteria was used for production runs, there was variability in the potency of active pharmaceutical ingredients produced and the facility was plagued by “broken” systems and equipment.
The programme also implied that patients had been injured by products made at the plant, a point strenuously denied by GSK in its statement.
“GSK strongly disagrees with 60 Minutes’ implication that patients suffered harm as a result of the Cidra issues,” said the drugmaker. “The FDA, the US Department of Justice, and Neil Getnick, Cheryl Eckard’s attorney, all stated there was no indication that patients were harmed as a result of the production issues at Cidra.”
GSK closed down Cidra in 2009, but maintains that this was for commercial reasons rather than a consequence of the quality issues at the plant, and was related to declining demand for the medicines made there.
Drugs produced at the plant included the antidepressant Paxil CR (paroxetine), Avandamet (rosiglitazone and metformin) for diabetes, Kytril (granisetron) for preventing nausea in cancer chemotherapy patients, and the antibiotic Bactroban (mupirocin).
Answering claims that it had caused problems for employees who raised concerns about manufacturing quality, GSK said: “the company strongly rejects any claim of retaliation for whistle-blowing.”
Phil Taylor
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