Tuesday, November 2, 2010

GSK pays out for contaminated drugs

You may recall last week I had a story up about Johnson & Johnson and their substandard quality controls, that resulted in massive recalls, which the FDA stayed quiet about though they were aware.

Johnson and Johnson is not the only problem in big pharma.
If only, if only.....

.....Glaxo Smith Kline (GSK) recently payed $750 million to settle charges for 'adulterated' drugs.
And the executives, who were warned about the drug deficiencies are still with GSK.

Five of the six senior executives cited by a whistleblower as part of a cover-up of contamination problems at the group's Puerto Rico factory are understood to still be employed by the pharmaceuticals company.


The whistleblower who repeatedly warned them of numerous product violations, was sacked for doing so, also received a settlement as part of this $750 million dollars.

Let's look at the warnings. For which drugs and over what time period? What were the whistle blowers concerns?

She believed company executives refused to acknowledge the gravity of the production violations – which included the wrong strength of pills being shipped – because it would delay the approval of two new drugs by the US Food and Drug Administration.

The court documents allege that Eckard, who had recommended the factory be shut until the issues were resolved, communicated the quality violations at the plant in Cidra to David Pulman, president of global manufacturing and supply; Janice Whitaker, senior vice president of global quality; Peter Savin, vice president of global quality assurance; Diane Sevigny, director of global quality assurance, risk management and compliance; and Jonathan Box, vice president of manufacturing and supply for North America.

After 10 months of repeatedly alerting a string of GSK executives to the problems, Eckard was sacked in 2003. In July of that year, she telephoned JP Garnier, GSK's then chief executive, who declined to take the call. Eckard then reported the company to the FDA in August 2003.

The company has pleaded guilty to five breaches of quality standards, but denies all other
allegations made by the whistle blower.

Some of the drugs that were 'adulterated' included Kytril, an anti-nausea medication, Bactroban, anti-infective and Avandamet, a diabetes drug.
Another drug mentioned in this piece, is Paxil.

The investigation largely concerned the manufacture of defective pills including the Paxil antidepressant at Glaxo’s plant in Cidra, Puerto Rico, between 2001 and 2005.

Some drugs were contaminated with bacteria or had a cracked coating that rendered them ineffective. Some did not meet federal standards because they were too strong or too weak, and others were mixed with different medicines—and then sold in the same bottle.

To recap whistleblower tries for ten months to get someone to address the contaminated/substandard drugs being manufactured in Puerto Rico.
GSK ignores, then fires her, not giving a hoot about their toxic pills contaminated with bacteria and of substandard quality.
GSK is then given slap on the wrist in a form of a payout. $750 million is nothing for a company that raked in billions in profits on last years swine flu vaccine alone.

No one knows if the genuine concerns are being addressed and fixed? I mean they settled the suit. Payed the whistleblower. But have they fixed the problem? Or did they just make it go away? A "sweep it under the rug" kind of thing?

2 comments:

  1. well La dee Da, and this makes for How many times that GSK has been caught fucking up? I count at least six and has it ever hit the main stream news so that people could be informed as to the bullshit that this company spews out? (answer is) NOT A FUCKING CHANCE.

    Notice how that fat fuck David the butler to Big Pharma Jones hasn't shown his Pig jowled face with even so much as an ooops about the swine flue mess?

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  2. Hey silv.

    I checked back through the blog on how many times I have noted here GSK has been fined.

    I found one regarding Paxil and the cover up of knowledge of birth defects with, of course, a pay out.

    Wyeth and Pfizer have also had their scandals.

    Has it ever hit the mainstream media and got some real coverage of this issue "the problem with big pharmaceuticals" no.

    Since most people get their news or what passes for it from the boobtube, they are destined to remain, well.. boobs.

    (No, I am not talking women's breasts either)

    I mean an ignorant or foolish person -a boob.

    And I have noticed David Jones is MIA.

    But, he will return

    ReplyDelete

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