What’s in the drugs that you take? You may have done your research and know exactly what they’re composed of. You may even know how they’re likely to affect you.
But breaking news reveals that you can’t believe what you read on the labels. It’s anyone’s guess what threat these drugs may pose. That’s because the world’s leading drugs manufacturer is selling contaminated and ineffective drugs. And it’s been doing it with full knowledge for a decade.
A new civil and criminal lawsuit has blown the lid off its illegal operations – which date back to at least 2002.
A whistle-blower brought the case against the company. And provided proof that the company’s biggest plant has been making bad drugs for years. Worse, the company’s top executives knew all about it and did nothing to stop it.
At least 20 leading drugs – including Paxil and Avandia – have been shown to be either potentially risky or virtually useless… because of illegal practices at the drug maker’s biggest production plant.
And the public have been paying $5.5 billion each year for drugs produced specifically at that plant.
We reveal the dark secrets of the world’s number one drug maker.
History of Illegal Activity
The drug maker is GlaxoSmithKlein. Their biggest plant has been producing contaminated drugs for years.
Now they’re paying $750 million to settle a whistle-blower lawsuit. This case is making history. That’s because earlier cases against drug makers have only focused on illegal marketing.
But this case is different. It’s the first ever case of its kind. It successfully shows that the drug maker knowingly sold drugs that were contaminated with micro-organisms. Or drugs that didn’t actually contain active agents.
While this huge facility (based in Puerto Rico) was producing over $5.5 billion of drugs each year, top executives first ignored – and then suppressed – the truth that the drugs were potentially harmful.
It’s the first case to provide a glimpse inside the industry. It sheds light on one of the leading drug makers. Shows how it operates its premier plant. Reveals that plant to be riddled with contamination. And is pumping out at least 20 different drugs that are ineffective at best and potentially dangerous at worst.
Blowing the Whistle
The whistle blower is Cheryl D. Eckard. She was formerly Glaxo’s global quality control manager. According to her testimony, she warned Glaxo about contamination problems at the plant back in 2002.
These problems included:
- Contaminated water systems.
- An air system which allowed products to be cross-contaminated.
- A documented inability to ensure sterility of intravenous drugs for cancer.
- Pills of differing strengths being mixed in the same bottles.
But her warnings went unheeded. She was shocked by the lack of response over so many breaches. So she sent further warnings to senior management. She again noted all the problems at the plant.
Again, she got no response. And her reports were not acted upon. So she brought it to the attention of the top executives at the company.
Once more she hit a wall of silence. So she threatened to call the FDA. But strangely the drug maker didn’t seem to care. Instead they responded by making her redundant.
She gathered her evidence and took matters into her own hands. She signed up a team of lawyers and sued Glaxo. That spurred a government investigation, which revealed her allegations to be true.
“This is not something I ever wanted to do,” says Eckard. “But because of patient safety issues, it was necessary.”
Drugs that were seized at the plant revealed dismal results under testing.
The plant-produced antidepressant drug Paxil was missing key compounds. It offered no health benefits at all. Quality control experts determined that a layer of active ingredient had spilled from a layer of a barrier chemical during its production. Many batches of the drug only contained the barrier chemical.
Other affected drugs include:
- Avandia (diabetes)
- Avandamet (diabetes)
- Bactroban (ointment)
- Coreg (heart)
- Kytril (anti-nausea)
- Tagamet (acid reflux)
Oddly… previous FDA inspections of the plant had missed these problems.
Rising Tide of Lawsuits
Manufacturing competitor Pfizer has also settled four whistle-blower cases in recent years. Last year it paid $2.3 billion to quietly settle one single whistle-blower suit.
But the Glaxo lawsuit is the first to breach the production secrets of a major drugs manufacturer. It may be the first of many.
That’s because drug makers have laid off thousands of workers during the recession. Some of those redundant workers have filed whistle-blower lawsuits.
Whistle-blower suits – if successful – earn big money for the people bringing them. Eckard has won a cut of the Glaxo settlement. In this case that amounts to $96 million.
Such a climate may bring further truths to light about the drug makers. The New York Times reports there are many more suits, all currently sealed: “The threat to the industry has been largely unnoticed because the growing mountain is obscured by a wall of judicial secrecy.”
Tony West, the assistant attorney general in charge of the case, says there are hundreds of other similar lawsuits brewing. In fact, more suits are filed almost every week.
For now, Justice Department officials say the drug maker will pay $150 million to settle criminal charges. And another $600 million in civil penalties.
“When you buy a drug, you expect that drug is what it purports to be,” says Carmen M. Ortiz, the United States attorney for Massachusetts. “You don’t expect it to have micro-organisms. Or not be sterile. Or not have [any] power.”
It’s one more reason why it’s always worth considering safe, natural alternatives to drugs. And NHD will continue to bring you news and updates on these solutions… as they come to light.
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