You may remember this story from last November when it first hit the news. But in the 60 Minutes interview above, whistleblower Cheryl Eckard opens up to reveal even more disturbing details about the gross negligence at the Cidra pharmaceutical plant, run by one of GlaxoSmithKline's subsidiaries.
They eventually pleaded guilty to the felony crime of distributing adulterated drugs, yet not one single person in charge of the debacle went to jail!
Why Should We Trust Felons?
Once you've been exposed to the seedy underbelly of the drug business—the LEGAL drug business—you can't but realize that we're dealing with a very large group of criminals and felons. There's really no nicer way to put it.
After all, companies are run by human beings. Company logos don't make decisions by themselves.
As it currently stands, the company usually gets away scot free or with a slap on the wrist. Oh, they do have to pay fines, and in this case it was three quarters of a billion dollars, but when your profits are over $100 billion, it's is not much more than a speeding ticket inconvenience and widely regarded as merely the cost of doing business.
Unless actual individuals are held accountable, what's to stop those individuals from perpetrating the same crime again and again? Nothing!
No less than 19 drug companies made AllBusiness.com's Top 100 Corporate Criminals List for the 1990s.
What does that tell you?Keeping that fact in mind, Eckard's story about the goings-on at the Cidra plant in Puerto Rico becomes less shocking. Not because it isn't bad, but because it's already quite clear that 'questionable business practice' has become 'standard practice' within the pharmaceutical business.
What Happened at the Cidra Plant?
The problems at Cidra were first revealed by an FDA inspection. Eckard's quality assurance team was then sent in by GlaxoSmithKline (GSK) to address those concerns, back in 2002. But when Eckard uncovered even more disturbing issues than those found by the FDA, her superiors simply ignored her.
Many may not realize this, but the FDA does NOT inspect drug manufacturing facilities at regular intervals. In between spot-checks, drug companies are left to police themselves. In the past year alone we've seen numerous instances where this self-policing has failed, as a long list of drugs have been recalled for a variety of different quality and safety issues.
At the time, the Cidra plant was making 20 patented drugs for the US market, and when Eckard saw what was happening at the plant, she was shocked, and worried about patient safety. "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," she tells 60 Minutes' correspondent Scott Pelley.
Some of the problems included:
* Using water contaminated with bacteria to make tablets
* Failures on production lines that led to inconsistent dosages
* Employees contaminating products by not following procedures
As an example, Eckard claims employees would open the lid to the sealed tank containing the anti-bacterial ointment Bactroban, and stick half their bodies into the tank to scrape it out. "It saved money," she replies when asked why anyone would consider doing such a thing. But that's not even the worst of the problems Eckard uncovered.
GSK Knowingly Put Patients' Lives at Risk to Save a Buck
Due to various production line failures, powerful medications were also getting mixed up. Potent and potentially dangerous drugs were literally ending up in the wrong bottles! The antidepressant Paxil was mixed into bottles of Avandia, a diabetes drug. And Avandia was found in packages of the over-the-counter antacid Tagamet. All in all, Eckard identified nine different mix-ups of various drugs.
She urged the vice president of quality assurance for North America to stop the trucks from leaving the dock the day she discovered the mix-ups, and to shut down the factory and contact the FDA. But nothing happened… And, when one such mix-up was later discovered by a patient, GSK denied it ever happened. But "we all knew, they all knew it was real," Eckard says.
Finally, after eight months of reporting problems at the plant, Eckard sent a summary to seven executives detailing the numerous quality problems, warning that if the FDA knew of these issues, the plant would likely be seized.
Just weeks later, Eckard was out of a job. Concerned for the welfare of patients taking the affected drugs, she blew the whistle and notified the FDA. Federal agents searched the plant and seized hundreds of millions of dollars' worth of defective drugs. In the end, GSK pleaded guilty to a felony: knowingly manufacturing and selling adulterated drugs, manufactured between 2001 and 2005.
Their punishment for putting people's health at such incredible risk?
A grand total of $150 million in criminal fines and $600 million in civil penalties—little more than a slap on the wrist. None of the actual people who allowed it to happen suffered any ill consequence as a result of their actions, aside from the one who blew the whistle...
GlaxoSmithKline (GSK) Blockbuster Drug Now Proven Too Dangerous
Meanwhile, GSK's blockbuster diabetes drug Avandia made headlines again last year when it became clear that the drug not only had major risks, but that GSK kept the dangers of the drug under tight wraps—for a very long time.
As it turns out, GSK spent 11 years covering up trial data that showed that Avandia was a risky drug for the heart—again providing indisputable evidence that the drug paradigm is about money, not health. Avandia topped the list of drugs linked to fatal adverse events in 2009, according to an analysis of U.S. FDA records, with 1,354 deaths reported that year alone. As a result, the FDA recently decided to restrict access to the drug.
In the US, Avandia is now only available to new patients if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take a different drug for medical reasons. Europe decided to ban the drug due to its exaggerated health risks.
What Can You Expect from GSK in the Future?
Well, considering the fact that media mogul Rupert Murdoch's son, James Murdoch, is now a member of GSK's corporate responsibility committee (a position he entered in May 2009), I predict we'll see more of the same types of cover-ups in the future.
James Murdoch, as you may know, is also the chairman and chief executive of News Corporation Europe and Asia, and chairman of BSkyB. I can only imagine the extent to which GSK can benefit from having a media mogul on their pay roll. Clearly they've thought this one through, and it makes perfect sense when you consider the clout they need to keep the media quiet about their various wrongdoings...
Having Murdoch in a role to oversee their corporate responsibilities is like having a top mobster as the god-father of your child. I think it's safe to say that if strings need to be pulled, they will be pulled—hard.
Meanwhile, Scam-Buster Efforts by States and the Feds Continue
Fortunately, states' attorneys general like Zoeller are gaining ground in gathering support for rooting out the criminal acts that Big Pharma continues to perpetuate. More and more, organizations like the Bureau of Investigative Journalism, the False Claims Act Legal Center, and Politicol News are starting to investigate and publicize the illegal – and criminal – actions that these companies have been getting away with for years.
Last July, Health and Human Services Secretary Kathleen Sebelius also announced the formation of the Healthcare Fraud Prevention and Enforcement Action Team, which together with the Department of Justice, US Attorneys' Offices and other federal agencies will target healthcare and drug fraud.
Thanks to the federal False Claims Act, state and federal investigators have a gun that they can use to hunt down and prosecute these heinous crimes with. If you visit the False Claims Act Legal Center website, you'll get a hint of just how much this type of corporate crime has been going on. One thing should be crystal clear at this point though, and that is that the drug industry simply cannot be trusted. They have the criminal history to prove it.
A Safety Issue Even More Disturbing than that of Unsafe Drugs
One aspect that truly worries me is that while the criminal cases we've seen in the past several years are related to drugs, many of these companies, including GSK, also produce VACCINES.
And guess what?
They're typically not liable for damages from, or harm done by, contaminated or otherwise dangerous vaccines! We've recently seen evidence of "mistakes" in vaccine manufacturing as well, but vaccine makers are rarely if ever punished for these willful errors and omissions, which should provide you some further food for thought.
Remember The Dr. Oz Show Today
Last Tuesday I was in Manhattan to film The Dr. Oz Show where he actually allowed me to mention a number of these issues. I suspect some of the footage will not be aired but my guess is most will. Please be sure and tune in. You can see a trailer for the show here. You can go to this link to find out where it is aired in your area. If you want to watch it right now though you can go their site and view it. For those of you wondering about the astaxanthin I discuss on the second segment, we hope to have it available on the site in a few weeks.