The woman who blew the whistle on the production problems plaguing the now-shuttered GlaxoSmithKline plant in Cidra was interviewed on 60 Minutes on Sunday, marking the first time she has spoken publicly of the manufacturing breaches.
In the report, Cheryl Eckard — a former global manager for quality assurance for the British pharmaceutical — detailed how she uncovered “broken” procedures at the plant when she arrived there in 2002, leading a team to inspect the problems at the plant. She said her concerns, reported to higher-ups, fell on deaf ears.
“All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career,” she told 60 Minutes.
Among other things, she pointed out that water tainted with bacteria was being used in the production processes of major drugs, manufactured drugs were either too strong or not strong enough upon output, GSK workers were cleaning out vats of anti-bacterial medication in unhygienic ways, thus contaminating the final product, and different medications were being packed into the same bottles.
“Yes and that’s shocking,” she said, noting that she had identified nine cases of packages that mixed drugs, including bottled that contained Avandia (diabetes) mixed with Tagamet (antacid) and Paxil (antidepressant) with Avandia (diabetes).
Furthermore, she found mislabeled products, including Paxil, she said.
During the report, entitled “Bad Medicine: The Glaxo Case,” Eckard said she asked her higher-ups to report the problems to the Food and Drug Administration or shut down the plant, neither of which happened.
The Cidra plant — which once produced about 20 of the company’s most popular medicines — was closed in 2009, leaving 900 people jobless.
Raising a red flag to all the problems cost Eckard her job in May 2003, an action that prompted her to file a lawsuit in 2004 under the “whistleblower” clause.
(Credit: 60 Minutes) Ian McCubbin
In October 2010, GSK was ordered to pay a historic $750 million settlement with the U.S. Department of Justice related to the case.
During the 13-minute, 60 Minutes report, Ian McCubbin, a senior vice president for Glaxo, defended the manufacturer’s past actions, saying the company has “worked really really hard to resolve those issues.”
GSK regrets the plant’s problems, he said, “but we’ve learned from it,” he said.
“We spend $600 million each year to make sure our plants and equipment are state of the art,” he said, noting Glaxo has 80 plants around the world, none of which operate the way Cidra did. All are supposed to follow the same quality assurance system.
“The difference between Cidra and all the rest plants was the effectiveness with which that quality system was implemented. It was much weaker which resulted in the compliance issues that occurred,” McCubbin said, adding GSK had been working with the FDA before Eckard arrived at the Cidra plant.
In a separate reaction issued Monday, GSK also denied it had retaliated Eckard for her whistleblowing, noting “in fact, employees are encouraged to report any concerns they might have to management or through a confidential compliance hotline. Issues raised are investigated, and company policy prohibits any retaliation against employees.”