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Of all the things that you trust everyday you want to believe that 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 that 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 tonight she will.
Her story opens a rare window on how one company traded its good name
for bad medicine.
Cheryl Echard worked in Glaxo quality control
and over ten years she'd risen to become a manager of global quality assurance.
Her job was to inspect
plants like
this Glaxo facility in North Carolina
to make sure that the drugs have the right ingredients, right potency and met
government standards for purity.
In 2002 Eckert 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 US.
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.
The worst, because so many things behind these walls were going wrong at once:
Eckardt says water use 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 Backtroban,
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. But this product is supposed to be free of bacteria. Why would they do
that?
It's saved money.
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?
Yes. And that's shocking, that's shocking.
Eckard says this 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 anti-depressants, mixed with Avandia diabetes drug. When you saw
these mix-ups happening,
what did you do?
I contacted the vice president quality
for North America and I told him that he needed to shut down the factory and
call the FDA. - Shut the whole thing down?
Right, I urged him to stop the trucks that were leaving
the dock that day. - What happened then?
I went back to work
and waited
for
the news
that they had called the FDA,
or that they had stop shipments,
and it didn't happen.
Eckardt says as the mix-ups continued, a pharmacist called the company
with a story about a mix-up involving the powerful antidepressant Paxil
in its 10 milligram dose.
The patient
was an eight-year-old boy.
A grandmother
come in to pick up this schoolboy's perscription.
And in front of the pharmacist, she opened up the bottle.
She tore off the induction seal. And she looked at it. And she became upset. And she said: "I
knew that his medicine has
always been yellow. But last month it was pink. And he's been so sick.
And what did that mean,
the yellow and the pink?
Paxil ten milligrams is yellow.
It's not pink.
There is a version of Paxil that is pink.
Paxil CR is 25 milligrams. If that is what the pills were, the boy was
getting two and a half times his prescribed dose.
Eckard says that she has assigned one of her investigators to the case and found
that both Paxil doses were made on one production line, which led her to a
theory of how the mix-up could have happened.
Maybe there was still Paxil in the hopper,
the filling hopper when they switched out the bottles and changed out the
labels. So in that batch some of the first bottles that went through were labelled
10 milligram and they were actually 25. She says she took her
findings to the same vice president
that she had asked to shut down the plant
five months before. I took it and I handed it to him
and I said to him, you know,
read this
he put his hands
over his face
and he said, Oh my God, Oh my God.
Did they shut down the plant then?
No, they filed a report with the FDA that said
that the mix-up was not real
and did not happen at the factory. We all knew,
they all knew
it was real.
The Glaxo report to the FDA Cheryl Eckart is talking about
said it was extremely unlikely the Paxil or mix-up occurred at Cidra.
We don't know what happened to the boy because drug incident reports don't
contain names but the Glaxo note to the FDA said "there were no adverse
reactions".
The vice president that Eckard says she spoke to
is no longer with Glaxo and he declined to talk with us.
Glaxo denies Eckard's allegations. And that it ever lied to the FDA.
In fact,
the company was eager to tell us that it has learned from Cidra.
Ian McCubbin is a senior vice president from Glaxo headquarters in London.
We regret what happened in Cidra.
But we've worked really, really hard to resolve those issues. We spent
$ 600 million every year on make sure that our plant and equipment
is state of the art. Would you say that the company was chastened by all of this?
No, I'd say the company was
very disappointed that this occurred
and that we regret that this occurred.
But we've learned from it. And what you learn from, you become stronger.
You have how many plants around the world?
We have about 80 plants around the world now. - Do any of them operate the
way Cidra did?
Absolutely not. - So how did Cidra go wrong?
They all operated to the same standard, to the same quality
system that we had in place.
The difference between Cidra and all the rest of the plants is the effectiveness
with which that quality system was implemented. It was much weaker and that
resulted in the compliance issues that occurred. - Cheryl Eckard says that she was issuing
warnings and no one was listening.
I don't know Cheryl Eckard. And I don't all the details of her
accusations. What I do know is that we were working with the FDA before
Cheryl went to that plant. It was an FDA inspection that first revealed problems
at Cidra.
And that's why Glaxo sent Eckard's team in to resolve those FDA
concerns.
But Eckard says, she found much more than the FDA did.
FDA inspections of drug plants are only occasional, so it's up to drug
companies to police themselves.
Probably most drugs are safe that
people are taking, but there are scary examples like this that certainly raise
questions. Dr. Jerry Avorn of Harvard Medical School is one of the
nation's leading authorities on pharmaceuticals.
He says that Eckard's story is an extraordinary look at what can happen
when there aren't enough investigators to follow-up on the federal inspections.
The fact that there were so many different kinds of problems and that
there were even other issues about diabetes drugs and antidepressants on
the same line getting allegedly mixed together.
The sterility issues, it speaks of a really pretty chaotic, out of control
manufacturing process. This was not apparently one isolated incident. It just looks
like nobody was minding the store at this plant. - What do you say to
someone who says, "Well the drug manufacturing process is very complicated
very hard to do there are bound to be mistakes?" - Just because something is
complicated doesn't mean it's okay to get it wrong. We don't accept that of our
brain surgeons or of our airlines,
or of other complicated things in society.
The reason we pay so much for drugs - more than any other country - is that we expect
that in exchange for those high prices, the companies are gonna actually
manage their manufacturing processes carefully.
Cheryl Eckard says her first warning to shut down the plant at Cidra came in
August 2002.
She continued to work, seven days a week, reporting to executives,
but nothing seemed to be changing on the factory floor and
the frustration was taking its toll.
The director of manufacturing at the factory,
maybe he was
the VP
of manufacturing at the factory,
he pulled me aside and said,
"we can all tell that you've been crying.
You come here every day
and your eyes are swollen
because you've been crying. So I want to ask you to stop that."
And I said to him, 'You know, I do cry.
I cry at night. I cry in the morning
And what I don't understand is why I'm the only one. Why aren't you crying?
After eight months of reporting problems at Cidra,
Eckard sent a summary to seven executives detailing nine high-risk
areas at the plant,
including the mix-ups, the water contamination and the problems
with sterility.
She warned that if the FDA knew what the company knew,
the government could seize the factory.
Weeks later,
she was out of a job.
Glaxo said it was downsizing.
Still worried about patient safety, Eckard took the same information she had
sent to her Glaxo bosses
and turned it over to the FDA.
Just as she had warned, federal agents executed a search warrant at the plant and
ultimately seized defective drugs
worth hundreds of millions of dollars.
This case goes right to the heart
of patient safety.
Neil Getnick and Lesley Ann Skillen are Eckard's lawyers.
And under the federal whistleblower law,
they filed suit on behalf of the federal government
claiming that Glaxo had defrauded the taxpayers.
How this is fraud against the U.S. government?
Pharmaceutical drugs are paid for by our Medicare program for the elderly,
by our
Medicaid program
for the impoverished.
And here we have a situation where
hundreds of millions of dollars
were paid for adulterated drugs
through our Medicaid programs. Glaxo pleaded guilty to a felony.
It admitted it distributed adulterated drugs Paxil CR, Avandamet (a diabetes drug),
drug
Kytril (a drug given to cancer patients), and Bactroban.
All together, the company paid $ 750 million to
settle the criminal conviction and Ceryl Eckard's suit. Can anything like this
happen at Glaxo again?
I absolutely hope not. We will work really hard to resolve these issues and make
sure that our quality management system is in place and robust.
The plant at Cidra is closed.
Glaxo says no drugs made there are on the market today and it says there is no
evidence that anyone was hurt by the defective medications.
Under the whistleblower law,
Eckard was rewarded with a percentage of the millions that the government
recovered in the fraud suit. Her
portion
comes to $ 96 million. You know
that there are people watching this interview who are saying, 'Well, she did it for the
money".
And to them you say what?
That I hope
and I pray
that their mothers
and their brothers and their children
have safer medicine today
than they had
before I filed that lawsuit. And I believe they will. Right?
I believe they will.