GlaxoSmithKline disputes report on '60 Minutes'

Posted January 3, 2011

GlaxoSmithKline (NYSE: GSK) said in a statement issued Monday that patients were not harmed as a result of production problems at a plant it once operated in Puerto Rico.

The drug giant responded after a CBS "60 Minutes" report aired Sunday night in which a former Triangle-based GSK quality inspector Cheryl Eckard spoke at length publicly about the case. Eckard was the whistle blower in the case, which GSK settled last fall for $750 million.

"GSK strongly disagrees with 60 Minutes’ implication that patients suffered harm as a result of the Cidra issues," said the company, which operates its U.S. headquarters in RTP.

In the television report, Eckard described the contamination and packaging problems she found. 

"All the systems were broken, the facility was broken, the equipment was broken, the processes were broken," she said.

Watch the 60 Minutes report

GSK operates its U.S. headquarters in RTP.

The GSK statement in its entirety follows:

"GlaxoSmithKline [GSK] issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company.

"GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality. It is important to note, however, that the issues outlined in the 60 Minutes story occurred in the past -- between 2001 and early 2005 -- and related to one manufacturing facility. GSK had been working with the U.S. Food and Drug Administration to improve the plant’s performance as early as 2001, before Cheryl Eckard was sent in 2002 as part of the team to address the issues cited by the FDA.

"GSK strongly disagrees with 60 Minutes’ implication that patients suffered harm as a result of the Cidra issues. 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. Massachusetts U.S. Attorney Carmen Ortiz herself stated: 'We did not uncover any evidence that patients were harmed from these adulterated batches.'

"GSK’s manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies – including the FDA – conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. GSK is committed to continuous improvement in our manufacturing processes. Patients should have a high level of confidence about GSK’s manufacturing and the quality of our medicines.

"GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA. The plant was closed in 2009 due to a declining demand for the medicines made there. The company strongly rejects any claim of retaliation for whistle-blowing. 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."


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  • Madonna Jan 3, 2011

    Perhaps this is another example of "Lean Six Sigma" gone bad. Just ask Toyota about that.

  • bigal02282 Jan 3, 2011

    "It's funny to me how a lot of you keep pointing the finger at 'big corps'"

    Keep laughing. Corporations are run by managers. Their allegiance is to profits and shareholders. Keeping your head buried in the sand is exactly what they want. It's been happening since the mid 1800's when large corps were basically born. The US tried dismantling several of the worst once at the beginning of the last century. As soon as people begin to forget about their past acts, they start them all over again. It will always be that way if we as a society are willing to let them continue.

  • Crayzee1 Jan 3, 2011

    It's funny to me how a lot of you keep pointing the finger at 'big corps' Ummm, a big corp, is worked by average americans. Any problems at most companies occur from the workers who fail to do their jobs. You really think the CEO knows that someone on the factory floor is fudging reports? Please people, these same drugs companies make the medicines that save our lives. Are they perfect? No they aren't, because they are run by people. Ordinary everyday people that make some mistakes, not some super evil madmen bent on taking over the world.

  • djofraleigh Jan 3, 2011

    Lesson learned: Use Wake County workers, Glaxo!

  • Immigrant Jan 3, 2011

    To: wake_up_jeff_0 who comment "this woman got paid BIG time for exposing GSK..."

    This woman was fighting so you and I can get the right medication. She deserved to be paid for what she did.

  • bigal02282 Jan 3, 2011

    There is another great story today which should be the Poster Child for those who think the Government should deregulate about everything, close up and go home. Oh, and it's about a Big Business (oil & gas wouldn't you know, who should never be regulated because they all have our best interests at heart!) Read this one and then move there if you love de-regulation so much. "Pa. allows dumping of tainted waters from gas boom....."

  • junkyard Jan 3, 2011

    buh, buh, buh, we need tort reform!!!!

  • christinebbd Jan 3, 2011

    (my son's injury was to his face, he had to have an MRI, among other things...that's why the bill came to $14,000)

  • christinebbd Jan 3, 2011

    Who pays the illegals unpaid medical bills??? I DO! GRRRR My son had 14 stitches to close an injury, each stitch cost $750 in total. Money is stolen from my pocket from outrageous charges in order to cover the unpaid medical bills of illegals.

  • smalldogsrule Jan 3, 2011

    Madonna- For what it's worth, PUERTO RICO is not "south of the boarder" (btw- your hatred of Mexicans is duly noted) Puerto Rico is in the Caribbean yes, BUT PUERTO RICANS ARE AMERICAN CITIZENS, and to boot, labor in Puerto Rico is just as costly as it is here in the continental United States.