Glaxo Whistle-Blower Lawsuit: Bad Medicine

[sabra]

Source: CBS News

Scott Pelley Reports Interviews Whistle-Blower Cheryl Eckard

(CBS) Of all the things that you trust every day, you want to believe your prescription medicine is safe and effective. The pharmaceutical industry says that it follows the highest standards for quality. But in November, we found out just how much could go wrong at one of the world's largest drug makers. A subsidiary of GlaxoSmithKline pleaded guilty to distributing adulterated drugs.

There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough. It's likely Glaxo would have gotten away with it had it not been for a company insider: a tip from Cheryl Eckard set off a major federal investigation.

...

In 2002, Eckard was assigned to help lead a quality assurance team to evaluate one of Glaxo's most important plants, in Cidra, Puerto Rico. Nine hundred people worked there, making 20 drugs for patients in the U.S. But Eckard says that when she saw what was happening to some of the company's most popular drugs, she couldn't believe it.

...

The worst, because so many things behind the walls of the plant were going wrong at once: Eckard says water used to make tablets was tainted with bacteria; failures on production lines made some drugs too strong, some not strong enough; and the employees were contaminating products, including the anti-bacterial ointment Bactroban, which was made in a sealed tank to prevent contamination.

"They were opening up the lid and then they were sticking their body into the tank and scraping it with like a paddle," Eckard said.

"But this product is supposed to be free of bacteria. Why would they do that?" Pelley asked.

"It saved money," Eckard replied.

As her team continued its evaluation of the plant, Eckard says she discovered something much worse than contamination: because of failures on various production lines, she says that powerful medications were getting mixed up.


Read more: http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247.shtml?tag=stack

[drm604]

1. K&R

:kick:

[TalkingDog]

2. Oh My Fucking God

Eckard says a chart that she produced for company executives shows the kinds of mix-ups that were happening at Cidra. She identified nine, including Avandia diabetes pills mixed in packages with over-the-counter Tagamet antacids and Paxil antidepressants, mixed with the Avandia diabetes drug.

[BonnieJW]

3. This was an incredible piece.

It makes me even more averse to drugs.

[WanderingWombat]

4. It takes a lot of effort to screw something up that badly

I've worked in the biotech/pharmaceutical industry for almost 20 years now. It takes a colossal effort to have so many things go so wrong. It's not an accident. It can't be. An accident happens, you discover it, you isolate a batch, you perform your RCA/CAPA, you ensure it doesn't happen again. If it does, you do it all again, this time taking disciplinary actions against those involved. There is no such thing as a third strike in this.

No tainted product should ever hit the market. Ever.

Glaxo was after profit, and profit alone.

They fostered an atmosphere in that plant that quality didn't matter. Just get the stuff done and make things look right at the end of your shift. Everyone from the lowly manufacturing techs on the production floor to their management chain, to Quality Control techs and their chain of command, to Quality Assurance people reviewing the batch records to ensure compliance, to the officers of the company had to be involved directly or complicit in this.

Heads, very important heads, at Glaxo have to roll for the public to regain even a modicum of trust here.

[flamin lib]

5. My Doctor and I have a running argument about drug companies

and whether they would knowingly sell harmful drugs.

[zalinda]

7. Ah, wasn't there a drug company that sold

tainted products to hemophiliacs, who later got aids? And they knew the blood product was tainted.

zalinda

[cutlassmama]

11. Yes and most of them died.

[keepCAblue]

6. In '97 or '98 I worked for a company that went in to audit the GSK Puerto Rico plant

This was an audit in prep of contracting out a major biz contract to GSK...what our auditors found was appalling -- horrific working conditions, zero quality control, no ISO certification or standardized good manufacturing protocols. The place was filthy and the plant workers were untrained and overworked. Obviously, they didn't win the contract.

And yet our gov'ment bans affordable Canadian pharmaceuticals from the U.S. due to lack of quality control oversight? Pure bullsh*t. It is merely to protect the obscene profits the drug manufacturers are making off Americans by price gouging us to death for questionable quality drugs.

[Gin]

8. Johnson & Johnson has a plant in Puerto Rico....wonder if any

of J&J problems were there also..

[Bombero1956]

9. All the major pharma companies have plants in Puerto Rico

Probably because by doing business there they are exempt from some aspects of the Internal Revenue Code.
Minimum wage there is $4.10 unless the employer is covered by the Federal Fair Labor Standards Act.

[Bombero1956]

10. Some of the big drug companies in Puerto Rico

Most of these companies have more than one plant located there. For instance Johnson & Johnson has 10 plants there including plants that make Tylenol and Imodium. Phizer has 5 including 1 that makes Dilantin, Loestrin and Lopid.


* Abbott Laboratories
* Allergan Inc.
* Amgen Inc.
* Astra Zeneca Plc
* Aventis
* Baxter International Inc.
* Becton Dickinson & Co.
* Biovail Corporation International
* Bristol-Myers Squibb Company
* Clairant
* Cardinal Health Inc.
* Ceph International Corporation
* Eli Lilly and Company
* F.H. Faulding & Co. Ltd
* Glaxo SmithKline
* ICN Pharmaceutical Inc.
* Ivax Corp.
* Johnson & Johnson
* Knoll B.V.
* Merck & Co.
* Monsanto Company
* Mova Pharmaceutical Corp.
* Mutchler Chemical Company Inc.
* Mylan Laboratories Inc.
* Novartis Consumer Health
* Pfizer Inc.
* Procter & Gamble Company
* Schein Pharmaceutical
* Schering-Plough Corporation
* Watson Pharmaceuticals, Inc.
* Wyeth