Most of us have taken a prescription medication at least once in our lifetime. And despite evidence to the contrary, we want to think the drugs our doctors prescribe to us will cure our ills with no negative side effects. After all, the pharmaceutical industry tells us our well-being is of paramount concern.
Well, isn’t that special.
Many would argue their biggest concern is their bottom line profits. In November of 2010 we discovered that one of the world’s largest drug manufacturers, a subsidiary of GlaxoSmithKline, wasn’t really looking after our well being at all when it distributed adulterated drugs. However, it appears they had an eagle eye on the money.
They would’ve likely gotten away with what appears to be gross negligence, too, were it not for one whistleblower. More than likely medications tainted with bacteria, labeled incorrectly, or not the correct strength would have continued to make it to our pharmacies. However, thanks to a tip from a company insider, Cheryl Eckard, a federal investigation ensued and Glaxo has had to pay up BIG.
Until now Eckard has never told the public her story, but she revealed all in a 60 Minutes interview. Here’s an inside glimpse into how one pharmaceutical giant engaged in sloppy management and even worse medical practice . . . and suffered the consequences.One whistleblower’s tale.
Eckard worked in Glaxo’s quality control assurance division. Part of her job was to oversee manufacturing plants to make sure the drugs met certain government standards for ingredient potency and purity. After inspecting a plant in Puerto Rico she was shocked at what she found.
“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,” said Eckard.
Even worse, according to Eckard, the water used to make the pills was contaminated with bacteria. Workers were making some drugs too strong while others were not strong enough.
How could such shoddy practice be allowed?
According to Eckard, it saved money.
There is more. Even worse than bacterial contamination was the alarming fact that the medications were getting mixed up and placed in the wrong bottles. Eckard prepared a chart to show company executives just what was going on. In her chart she identified nine medications that were mixed in with other types of pills. For example, Avandia diabetes pills were mixed up with over the counter Tagamet antacids.
Shocked by what was happening she contacted the vice president of quality control in North America. Her advice to him was to shut down the plant and notify the FDA. Then, assuming her advice would be heeded, she went back to work and waited for the news that the problem was under control.
However, the problem wasn’t under control at all. The FDA wasn’t notified and the mixed up shipments were still going out. In the meantime an eight-year-old boy received the wrong dosage of the powerful antidepressant Paxil . . . two and a half times his prescribed dose.
What did GlaxoSmithKline do?
You would think there would’ve been an immediate shutdown of the plant. But according to Eckard, they simply filed a report with the FDA denying the mix-up. Surprised?
Glaxo denies all of Eckard’s allegations. It also denies ever lying to the FDA. Obviously there is much more to the story, but ultimately Eckard turned over all of her findings to the FDA and federal agents eventually seized defective drugs worth hundreds of millions of dollars.
Thanks to Eckard’s whistleblowing, lawyers filed a suit on behalf of the federal government stating that Glaxo was guilty of fraud. Since pharmaceutical drugs are subsidized through Medicare for the elderly, we have a case where hundreds of millions of Medicare dollars went to pay for adulterated drugs.Will anything like this ever happen again?
One has to wonder. In the end Glaxo pleaded guilty to a felony and admitted to distributing adulterated Paxil CR, Avandamet, Kytril, and Bactroban, paid a $750 million dollar settlement, and closed the plant in Puerto Rico.
Because of the whistleblower law, Eckard received a percentage of the money awarded to the government amounting to $96 million. While some may say she was watching out for her bottom line as well, Eckard says, “I hope and I pray that their mothers and their brothers and their children have safer medicine today then they had before I filed that lawsuit. And I believe they will. Right? I believe they will.”
One can only hope and pray.