Glaxo Whistle-Blower Lawsuit: Bad Medicine

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.

She's never told the public what she saw inside Glaxo, but now she has. Her story opens a rare window on how one company traded its good name for bad medicine.

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Glaxo Response to "60 Minutes" Report:
GlaxoSmithKline [GSK] issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company.

GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality. It is important to note, however, that the issues outlined in the 60 Minutes story occurred in the past -- between 2001 and early 2005 -- and related to one manufacturing facility. GSK had been working with the U.S. Food and Drug Administration to improve the plant's performance as early as 2001, before Cheryl Eckard was sent in 2002 as part of the team to address the issues cited by the FDA.

GSK strongly disagrees with 60 Minutes' implication that patients suffered harm as a result of the Cidra issues. The FDA; the US Department of Justice; and Neil Getnick, Cheryl Eckard's attorney, all stated there was no indication that patients were harmed as a result of the production issues at Cidra. Massachusetts U.S. Attorney Carmen Ortiz herself stated: "We did not uncover any evidence that patients were harmed from these adulterated batches."

GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. GSK is committed to continuous improvement in our manufacturing processes. Patients should have a high level of confidence about GSK's manufacturing and the quality of our medicines.

GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA. The plant was closed in 2009 due to a declining demand for the medicines made there. The company strongly rejects any claim of retaliation for whistle-blowing. In fact, employees are encouraged to report any concerns they might have to management or through a confidential compliance hotline. Issues raised are investigated, and company policy prohibits any retaliation against employees.

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Eckard worked in Glaxo quality control and over ten years she had risen to become a manager of global quality assurance. Her job was to inspect plants to make sure that the drugs had the right ingredients, the right potency and met government standards for purity.

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.

"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 told "60 Minutes" correspondent Scott Pelley.

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.

"Are you saying that different kinds of drugs were packed into the same bottle?" Pelley asked.

"Yes. And that's shocking," she replied.

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.

"When you saw these mix-ups happening, what did you do?" Pelley asked.

"I contacted the vice president of quality for North America and I told him that he needed to shut down the factory and call the FDA," Eckard said. "I urged him to stop the trucks that were leaving the dock that day."

Asked what happened then, she told Pelley, "I went back to work and waited for the news that they had called the FDA or that they had stopped shipments, and it didn't happen."

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[TerenceMix]

The "60 Minutes" report on CBS about GlaxoSmithKline (GSK) and its sale of adulterated drugs, including Avandia and Paxil, is one more reminder why the country is in bad need of a change on how drugs are tested prior to marketing and monitored after reaching the nation's pharmacies. After Eckard reported the multiple problems occurring at the Cidra plant, including contaminated drugs, pills mixed in with other types of medications and improper dosages, GSK willfully let thousands of these drugs enter the market to be consumed by unsuspecting users. Indeed, this went on for many months until Eckard turned everything over to the FDA. This conduct will not come as a surprise to anyone familiar with GSK's track record. GSK knew about studies reporting an increased risk of cardiovascular problems with Avandia a good 3 years before the story broke in 2007. GSK also knew that its irritable bowel drug, Lotronex, could cause ischemic colitis - a potentially fatal condition in which there is inadequate blood flow to the colon - even before it was approved for marketing. Americans are dying unnecessarily because we allow drug companies to do their own premarket studies, rather than an independent and impartial entity such as the National Institutes of Health. If you agree that we are in bad need of a change, I would urge you to go to my website at www.FDAReformPetition.com and sign my petition to Congress. With enough of us acting in concert, we just might make a difference.

[Bijan_Esfandiari]

Some critical comments concerning the amount of money Cheryl Eckard made in her whistleblower case miss at least three important points:

(1) Whistleblower payouts are based on a percentage of what companies have been bilking from the government (and the American public), sometimes in amounts reaching into the tens of billions of dollars, such as in Cheryl Eckard's case. Even a fraction as small as 1% of that income could result in a false claims act award of hundreds of millions of dollars. With so much potential income at stake to entice illegal activity, it takes a lot to deter the urge to do the wrong thing;

(2) Whistleblower laws provide not only protections, but serious compensation to those courageous enough to come forward with evidence of corporate fraud and corruption because it takes guts to take on a multi-billion dollar corporation. Whistleblowers protect consumers, get money back into government coffers and save taxpayers billions of dollars;

(3) When a whistleblower decides to "blow the whistle," he/she has no idea whether he/she will ever see a penny, much less millions or tens of millions of dollars. Whistleblowers usually only become whistleblowers after efforts to correct a problem have failed and, often times, only after they've been fired by the company for complaining. It is thus unfair to assume the motivation behind such lawsuits is simply monetary.

[SCRankin]

Anybody ever ask why we are on so many medications? I am a nurse and i am appalled when I see patients on 18 different medications. We all want a pill. Why do we have so much chronic disease in our population? We need to look at overuse of antibiotics, chemicals in our foods, chemicals in our environment to find our the cause not just use a pill to treat symptoms. Cancer in 20 year olds? It is not genetic, it is environmental. Most of the research in medicine is done pharma. If they can't make money off the treatment, the study will never be done. How sad...

[bjbentley]

I can't agree with you more, I knew I couldnt be the only person with these exact thoughts. Refreshing to hear you are in the health care industy. People are running scared, everyday the obituaries are filled with dying young people. When I was growing up, I didn't have friends with cancer or even know of any parents with cancer. This is progress? Its a money game, sell more drugs, advertise on TV in magazines, increase the costs for all of us to pay, if not in costs alone but the increase in soon to be mandated "insurance premiums".I concur. How sad......

[kylexy2]

It's great that there are people willing to do what's right. However, I really wish everyone would write to their congressmen to cap the whistleblower law, at say $5 Million. Does anyone really think that Ms. Eckhard wouldn't have taken the same actions if she had "only" received $5 Million?

[TCGIRL101]

Way to go Cheryl Eckard! I can't believe ANYONE thinks she'd do this for the money. From the beginning of the story, it was clear Glaxo would eventually fire her under the disguise of a job abolishment. FINALLY, a person with INTEGRITY! She informed leadership of her concerns, documented them, and they were ignored. If more people would "do the right thing," maybe our country wouldn't be going down the toilet. And who wants to be associated with a company that flies a shredded up American flag like the one hanging outside the plant that was eventually shut down? What a disgrace! Shame on you, Glaxo!!!

[Godhelpus123]

I couldn't agree with you more! I have personally heard my own horror stories and had a few experiences myself. It has to be one in five that have issues. This is more than just a conversation on this website. America "we are at great risk". If she had to go through all that to get to the bottom of this, imagine what else could be going on with our drugs. The other fact is, why wasnt that CEO sweating, he didnt even seem that concerned. I will tell you why, because he is CEO of that company, he will know exactly what he is getting and he will not get the wrong dose or medication and he knows it. Whereas the rest of the population is being played a game of "Russian Roulette". We simply need to understand why we are being played like this and why they take such measures for what seems to be murder. Isn't that what eventually happens to some. It would be entirely different if it were truly an accident. That we can understand,but today, we find our lives in and under the control of the FDA and other monopolies. We are not exercising our rights. Unlike the early days, when we didn't have exceptional medical care, we appreciated all that we could do to save a human beings life. What changed? What seed was planted? How is that we feel we can get away with this type of murder in plain daylight?

[rtcecil1]

This is just what is wrong with our justice system in America. Yes, Glaxo was in the wrong but thankfully no one was injured. But where is the justice in one whistleblower receiving 92 Million dollars not to mention how much her lawyers received. It is completely an OUTRAGEOUS amount. That amount of money would save millions and millions of people in a third world country. So if Ms. Eckard is truly concerned about saving people let us see her donate a lot of her money to charity. Meanwhile something needs to be done about these lawsuits or justice will never be served. It will become only about the money.

[nolapearl]

1. How do you know no one was injured? If you read the story, there was a little 8 yr old boy who got sick off the wrong medication. 2. It's all about the money for Glaxo - why aren't you upset about that? Would you feel the same way if one of your relatives died from bad medicine? 3. How do you know Ms. Eckard hasn't donated a large sum of her money to charity? And as far as the $92 mil - her lawyers probably received 40% of her $92 mil - which leaves her around $55 or $56 mil which she has to pay a large chunk in taxes so out of the $92 mil, she probably received about $35 mil - which is nothing compared to the amount of money that Glaxo received for tainted drugs.

[Godhelpus123]

Not sure that we should be so concerned with how much money Ms. Eckard received. She deserves what she received. She was held hostage in a job for years. And Thank God she stayed. We may never have known what was really going on and many people could have died or had damage to an organ and become debilitated. I suppose it comes down to whether or not someone has needed medicine or not. There is so much talk about overuse,it is not about overuse as much as misdiagnosing, negligent and diligent treatment without drugs, and as we have seen with Ms. Eckards story, improper handling of manufacturing the drugs. We should feel blessed to have been given the knowledge to make drugs to save lives when appropriate. Yet all we do is complain about it or speculate about whether or not someone really needs it. Let me ask you, why is that if we need an antibiotic for a bacterial infection we are told we shouldn't take it? Because of resistance? Ok, so if you don't take it, what are your chances then? Maybe you'll survive, maybe you won't? Why not make the right kind of drug to help. If needed. Ms. Eckard has done a great deed. She has saved many lives that could have been lost had this company gone further. This is a blatant case of "little guy" vs. "big guy" and it's wrong. We are all "Big", anyone who thinks they are better has serious insecurity issues. Thank you Ms Eckard, I hope you can read this.

[cattiej]

Mr. Pelley: On Monday (yesterday), I asked numerous people working at our local pharmacy where I buy our medications...I asked them if they saw your 60 minutes report on Sunday..All denied seeing it and all said they did't know anything about it or anything about medications. I would like to see you investigate more manufacturing plants in other countries and what plants are left in the U.S. My meds are made in Pune, India..they are diabetic meds. I am afraid every time I put on of the pills in my mouth that this might be the pill that will not lower by blood sugar but raise it or cause me to have a heart attack. I have no problems with my heart other that I am heartsick about this type of manufacture and the CEO's who work there, defrauding people and our government. Just think about our soldiers who are fighting or come home with serious injuries, how many of them have taken "bad medicine"?

[florn2604]

Somehow I don't believe Glaxo isn't the only one with quality control issues. I take Premarin (estrogen). 2 years ago I knew there was something wrong my prescription as I had constant hot flashes. I took it back to the pharmacy and asked if there had been a recall or if they could test it to see if what was in the label was what was in the tablet--even though the color and shape were correct. I was told there was no problem with the medicine. The same thing happened with the next bottle. Then I filled the Rx at another pharmacy. My symptoms immediately improved. Should this happen again, I will now contact the FDA. While we would all like smaller, less expensive government, these are the results. Big business just rolls over the consumer. It's all about greed. LB

[cattiej]

I urge Scott Pelley to do a story on the plants that are spread around the world, especially the country of India, Mexico and China. I feel that I had some bad synthroid medicine last spring and my TSH blood work was extreemly high and I Had never missed a day of taking it. My Doctor order on test on Thurs that was in the the 50's and he called me back to have one done on Saturday because the lab at the hospital thought there machine wasn't working correctly. I called the Rx company which is located close to Chicago and ask them where my meds were manufacture and they told me that was "privilaged information". I bought another bottle of pills that my Doc order and it was several weeks before I felt better. As a retired Nurse this is a front page story and story that should not be lost but talked about everyday. Not only are our meds being manufacture in other countries by other people, they are probably being manufactured in accurately and in very unsafe conditions. This is an accident waiting for a place to happen. One of these days, 100's perhaps thousands of people will die from pills they took that were contaminated. If Mr. Pelly needs someone to assists him in the venture or help any way, please let me know..I have been worried about this for several years...Just think our soldiers who are being hit by bullets may be taking medicine that could kill them instead of save their lives..All, this because the drug companies have outsourced the jobs to other countres. We is the President when you need him! Don't give up on this Mr. Pelley, you have just hit a little big of this big iceberg. JDT

[cattiej]

We all must remember that our soldiers who are fighting in this illegal war are taking Rx meds too..Our children, our grandchildren, our parents, our grandparents, our neighbors, our friends..what is going to happen when another bad "batch" of meds come out of another plant in some other country. The guy from Glaxo said they have 80 other manufacturing plants...Where are they located???
I think I said that I threw out my Glaxo toothpaste after watching this program, now I am looking thru my medicine cabinet and going to throw out any other Glaxo products. My Sensodyne toothpaste made by Glaxo didn't say what country is was made in either on the box or the tube.. I might have been made in Mexico, like a lot of Colgate is, from contaminated water and poor manufacturing conditions..Anyone know where Sensodyne toothpaste is made??