Karen was one of the kindest, sweetest people.
I was able to sit down with her
and her husband Tom in-person,
and just get to know them a little bit.
I remember her talking about her favorite color.
She was wearing purple.
She had a purple bracelet on, purple sunglasses.
She was really excited about the possibility
of her and Tom being retired recently
and being able to do things,
but I think the reality was sort of setting in that
some of that travel she had thought about
might not be happening because she was too sick.
Basically a pretty healthy 70 something year old woman
surprised to be diagnosed with liver cancer.
That was very aggressive.
Her doctors were surprised too.
When she received the recall notice from her pharmacy
she started to put pieces together.
If you are taking heart medication
as so many Canadians are,
you may wanna double check your label this morning.
The FDA has expanded the list of drugs
being recalled that contain valsartan.
A drug recall over cancer concerns
as many patients confused.
Researchers have linked that chemical to several cancers.
22 other countries have also already recalled the drug
for the very same reasons.
Karen had been taking valsartan
possibly for as long as four years,
she ended up dying recently from cancer.
They're testing 100% of the drugs
that come into this country,
is that how it works to keep me safe?
No, and I think a lot of people assume that for sure.
Everyone is pushing for cheaper drugs.
And what this one example shows is that
safety is one of the costs.
And we don't even know that we're being asked to pay it.
My name is Anna Edney.
I'm a health policy reporter at Bloomberg News.
I wrote the article titled Tainted Pills, Broken Trust
with Susan Berfield,
who is also a colleague of mine at Bloomberg.
Valsartan was a drug and it's used to lower blood pressure
which is something many, many Americans use.
I mean, the pills they were used by millions of people.
It was found that the drug had carcinogens in it.
I had followed issues with drug quality
for a really long time.
And this was sort of one of the worst ones that I had seen.
The chemical that had been found in the valsartan
the shorthand is NDMA.
It's a chemical that used to be used
in rocket fuel production
and is also now created through industrial processes.
It is created when food is smoked.
So that's why there's some concern
about eating too much bacon.
NDMA is also the reason that secondhand smoke is a problem.
It's a probable carcinogen that's created in many ways.
People who had been taking valsartan regularly
as most people do,
there was a concern that there could be some connection
to cancer of the liver,
in particular we knew the end result
was a contaminated medicine.
And then we began looking backward.
When a company files an application for a new drug
to the Food and Drug Administration,
they've done very large clinical trials
looking at the efficacy and the safety of a drug.
And these have lasted months if not years.
Generics are different though.
Generics are the drugs that have gone off patent.
The company that did the research into the drug
gets a certain 10, 20 year period
where they are the only ones who can sell it.
Then after that other companies can make
essentially copies of the drug.
What they have to show the FDA
is just that they work in the same way.
So they're not really doing these large clinical trials.
They're saying we took your formula
and we think ours works exactly the same.
So it should be fine.
Generics are much cheaper
because they don't have to bear the research costs.
So it become hugely popular.
Almost 90% of the drugs that everyone in America
is prescribed are generics.
The valsartan is the generic form
of a drug that Novartis created.
It was enormous success for Novartis.
Billions and billions of dollars,
among the most popular drugs on the planet.
When it went off patent, there were a lot of companies
that were rushing to create generic versions of them.
Over the past years,
more and more are being manufactured overseas.
That is largely a financial decision.
As we know now, labor and and often supplies
can be cheaper overseas.
There has been so much pressure on the medical system
to approve drugs that can be made more cheaply
and then to have them sold more cheaply
to American consumers.
The FDA tests probably less than 1% of the supply
that comes into the US every year.
And many of our drugs are coming
from particularly China and India.
And so not much of it at all gets tested.
It's a huge industry and the FDA is not all that big
and not all that well-funded.
And so they ask that the industry
keeps up with quality testing
that essentially it's up to them,
because they're the ones with their names on the line.
In China and India, the FDA has found a lot of issues
with quality control.
Generics don't bring in a lot of money.
So any ability to save something here and there
with the type of ingredient that you might use,
or the process you might use, the incentive is much higher.
And so the quality can suffer sometimes
when money becomes the bottom line.
Zhejiang Huahai was manufacturer of what's called
the active ingredient in the valsartan.
So they need essentially the part of the drug
that has the effect,
and then they would sell it to other manufacturers
who would kind of finish it with inactive ingredients
and the coding that you see so that you can take it.
Huahai was founded in 1989
and has been committed to supplying high quality medicine,
active pharmaceutical ingredients,
and advanced intermediates for our customers.
Huahai decided to use a solvent that was cheaper
than the one Novartis had been using.
They wanted to save money however they could.
They changed it to a solvent that's called DMF.
When Huahai changed the solvent
it said that it wasn't a huge change
and it landed the FDA but it said
that it wasn't a critical change.
Just that rephrasing was very important
because it would invite less scrutiny
and suggested that it was a pretty ordinary change
that was done for reasons
that were really very crucial to the process.
And both of those things proved untrue.
It was critical because the ingredients in it
reacted with ingredients in valsartan to form the NDMA.
One of the hardest parts with reporting the story
is that the FDA inspection process is very secretive.
So it can be difficult to get the documents.
Once you do get them through the FDA,
they're heavily redacted.
What we found in particular with Huahai is that
there had been inspections.
And the inspectors had found problems
like rusty and old machinery,
but more important than that discovered that
Huahai had found impurities,
essentially kind of in their testing.
When a company does quality testing,
some of the readouts sort of look like an EKG,
like a heart rhythm, they're waves going up and down
that are indicating what's in the drug.
And so the inspector found these peaks
that weren't supposed to be there.
The management at Huahai called them ghost peaks,
and he indicated that he never heard of that before.
He didn't know what that meant.
And later it was found out that that ghost peak,
what was indicating there was NDMA in the drug.
The inspector was worried enough
that he recommended the FDA issue
what's called a warning letter.
And that is the most extreme measure that the FDA can take.
And it essentially says putting company on notice.
The FDA decided not to do that when it came to Huahai.
And again, they said, we've noticed this problems,
we'd like you to fix them and report back to us.
And essentially nothing was done at that point.
So Huahai did not move immediately on the issue.
Novartis ordered valsartan active ingredient
from Huahai in 2018.
The company that had originally made the brand name
blood pressure medication was also making generics
and had bought 45 metric tons of the active ingredient.
It arrived in Switzerland and they began what we understand
to be routine testing of it.
And discovered some impurities, these peaks.
This peak that Huahai had seen, but ignored,
and Novartis that didn't look right.
And so they ended up trying to identify it
and they were able to identify that it was NDMA.
Novartis notified Huahai of the problem.
They notified the European drug regulators and the FDA.
They began recalling the valsartan
that was produced by Huahai.
At the same time, they started to test other suppliers
and began discovering that the problem existed
beyond just Huahai.
The FDA has expanded its recall
of a common blood pressure medicine due to cancer concerns.
Potentially millions of prescriptions
could be affected by this wide recall.
The recall began in the summer of 2018.
As we closed the story, the end of 2019,
there had been 52 separate recalls.
And that's because the testing was ongoing.
The recalls continue for other drugs
that have NDMA in them.
And that's something I think that is not going away.
The FDA ultimately developed its own test.
The FDA issued a warning letter to Huahai.
At the same time are trying to allay consumer's concerns
about the risk of developing cancer.
Repeating that though the levels of NDMA
in the valsartan were high,
they weren't really high enough to be concerned.
They said like everyone should not be checking
to see if they have cancer.
And yet there are many, many, many lawsuits
that are now in the courts for that exact reason.
We know there was this problem.
We know there are these people
who took the drug who are sick.
How closely we can make those connections
is something that probably will need to be answered
both by medical experts and in the courts at this point.
Millions of people took these drugs.
The impact I think, will be seen for a long time.
Safety concerns obviously there, but they came second.
To a lot of people that we spoke to they said,
well valsartan and the NDMA that we found in it,
that's probably just one example.
It's a terrible example because it's a probable carcinogen,
but it's probably not the only drug that's contaminated
or that will be contaminated,
because the system has vulnerabilities.
Those vulnerabilities will likely be exploited.
And you know, the consequences will be borne
by the people who have the least say
in how any of this happens.