Researchers at Valisure discovered that Zantac, the popular heartburn medication, is loaded
with a cancer causing substance known as NDMA.
They first notified the FDA about this in June of last year, but just in keeping with
the FDA, they did nothing about it.
The FDA slept on this issue and now it's killing Americans.
Joining me to talk about this is Daniel Nigh.
Daniel, let's start at the top.
What's the Zantac problem?
Well, Zantac breaks down inside of the body.
It's an unstable molecule, it breaks down inside with this toxin called NDMA and NDMA
is a radical, terrible toxin.
It causes cancer in numerous organs inside of the body.
You know, when they're doing animal studies and they want to induce an animal with cancer,
the toxin à la choice is often NDMA just because of how quickly it can induce a cancer
and it can induce a cancer at any site.
Okay, put it in perspective.
We're not talking about small amounts, as you point out, this is a chemical that when
a scientist wants to make an animal, induce cancer in an animal, this is their go to chemical.
That's right.
Now, there's a number that the, and of course, I trust nothing that the FDA says.
This is the most dysfunctional, it's almost a useless entity.
But they say, well it's 96 nanograms is going to be okay, but tell me how many nanograms
we, we're talking about with this.
Well, there's multiple different options out there, theories that we're still trying to
gather a little bit more information about.
You know, the petition from Valisure show that it may break down into as many as 4 million
nanograms.
Four million?
Right.
There's another, but that's with heating the sample, there might be some issues recognizably
with that.
But the other issue is when it goes inside of the body and it's, and it's combined with
nitrates, a high nitrate diet, like if you're eating pizza at the same time as taking your
NDMA, they've shown also that under a simulated testing that it may be hundreds of thousands
of NDMA breaking down there.
The FDA has even only tested the pill itself and found nano, you know, high nanograms of
NDMA in the pill itself.
Okay, let's back up on all that.
Okay.
First of all, we know we can begin here, that we know GlaxoSmithKline, if I'm betting the
farm on it, they phonied up results from clinicals.
I see it almost every case that I handle.
Well along those lines, Pap, in the 1980s GlaxoSmithKline had a, Glaxo back then because
keep in mind, Glaxo rode on the back of Zantac.
That's right.
That's their moneymaker.
That's how it became GlaxoSmithKline.
They forced the merger because they weren't in superior position without Zantac, we don't,
I don't know if they'd even be in the name.
Right.
You know, but they knew back in the 1980s that combined with a high nitrate diet that
it would break down the NDMA.
Let's talk about, okay, so right now we know we're way above the acceptable level of 96
nanograms.
Right.
We're maybe 3000 maybe 4 million.
Right.
The argument is that, that we're hearing from the other side is, well, oh that's only when
it's heated up.
The point is, we know this, when the Zantac goes into the human body and it can, it combines
with nitrates, as you're saying.
That's right.
Nitrate is something you can get from smoked sausage.
You can get it from any, look, food is packed with nitrates.
Bacon has more than you can count.
When you combine bacon with the Zantac pill, those numbers can hit three thousand, four
thousand, five thousand, that's what this is showing right now.
Absolutely.
Okay, so that's the first part of it.
The second part of it is that the company has known about this for a very long time.
They, and the FDA has known about it for a very long time and done nothing.
How long did it take the American FDA to react after this was already pulled off the market
around the world?
Well, FDA was the 43rd country to actually take some definitive action.
Okay.
We have countries out there like Guam and Singapore taking definitive action before
the FDA.
It's they, they slept on this, like they've slept on many other projects, as we know.
Tell us why in this case, the FDA and they had to save face, that's what I remember about
it.
They had to save face.
Tell us that story.
Well, the FDA tested the pill itself ,so they can see that there are hundreds of nanograms
in the pill.
And so once we even have hundreds of nanograms, that's over the threshold level of 96.
And the way that it actually started out is even our pharmacies understood what a catastrophic
problem this was.
They pulled it off the shelves, even the generic medication suppliers and now Sanofi, they
all pulled it off the shelf.
So really they all acted in the US well before the FDA took definitive action.
Sloan Kettering, probably one of the most important cancer research hospitals in the
world.
Right.
Comes out and says, we did this study.
It scares the bejesus out of us.
Tell us about that.
Well, we know, what we know now is that Sloan Kettering, the lead investigator, they made
the, was interviewed by Bloomberg and they had mentioned that as after they saw the study
results they polled, using Zantac in their hospital.
Okay.
So the hospital itself pulled the product out of their hospital and they're the ones
that did the study.
That's right.
They're the ones who did the study.
So we have pretty, pretty high confidence that there's going to be some significant
results in this study.
Well, surely it's going to be in one of the, one of the medical literatures.
Surely that study is going to be published so the public can know about that.
Tell me, when will it.
I think it was supposed to be published in JAMA, and it was supposed to be published
a few days ago, and here's, here's one of the big stories.
Now, you know, in terms of proving this case, we don't have to have Sloan Kettering study
to prove it, but it almost makes it a slam dunk when Sloan Kettering comes out because
it's so clear that if you're taking Zantac with a study like this, that it increases
your risk of cancer.
Okay.
So just to be clear, Sloan Kettering comes out with a report where they completely substantiate
everything that you're alleging.
The study shows it, it's very clear.
But nevertheless, even though that study, most of the time would be published in like
the JAMA or one of the medical pieces of literature, it's not showing up yet.
That's right.
And we, and if I'm guessing, because I've seen this before, I've seen the FDA get involved
and hush a story.
I've seen the, the lobby, the pharmaceutical lobby work together with the FDA to make a
story go away.
Is that what's happening here in your estimation?
Well, we've seen on numerous of these science blogs online that it's already leaked, that
JAMA pulled the study preemptively.
We don't know why.
You know, I hope, Pap, I hope that it's just to look at it and see if it's more accurate
and just, you know, make, give it a little bit more vetting and make sure that the findings
are robust.
But we've seen this time and time again, we've seen this in past projects.
Oh, I've seen it a dozen times.
Where the company or the FDA tries to figure out a way to bury a study and I'm concerned
that's what we'll be seeing here.
But here, we're talking about a product that causes cancer.
There's no question.
I mean, anybody that says no, there's no evidence, where do you find a scientist that comes out
and says, yeah, this does?
That the pill itself generates the chemical NDMA.
You understand what I'm saying?
Yeah.
NDMA, it's not contaminated with NDMA.
It goes into the body and synergistically creates the chemical NDMA, which is the chemical
that scientists use when they want to promote cancer in a laboratory animal.
And this is four, this is thousands of times higher than even the FDA's number, which is
96, it's thousands of times higher than that.
Right.
And so here we are right now, and my supposition here, I'll bet on this all day long and when
we do the discovery on this and take the depositions, what we will show, I promise you, will be
that lobbyists for the pharmaceutical industry and the FDA worked together to suppress the
Sloan Kettering study.
I promise you that'll happen.
Not only the Sloan Kettering study, but other studies.
Tell me what scientific, what's the best support for Zantac and it's cause to cancer?
What do you rely on?
Well, we know that Zantac breaks down inside of the, into NDMA.
Even the FDA has already known that there are some levels that it's, that it's breaking
down.
So that alone, there's a mountain of literature in terms of animal studies, in terms of human
dietary studies, in terms of occupational exposure studies that show that NDMA causes
cancer.
But we also even have a few studies that were done back in the day, not understanding that
NDMA was breaking down inside of the body, but done back in 2008 showing an increased
risk of breast cancer for people who were taking Zantac.
And also we've seen an increase in the risk of bladder cancer.
Bladder, colon, stomach, what do people need to be really aware of?
If they've been popping, look, there's people that pop Zantac all day long because they
have acid reflux, they've got ulcers, they've got doctor says, yeah, take as many as you
want and they pop them like, like candy.
What should they be conscious of?
Well, I think, I think some of the main cancers we're going to see is we're going to see bladder
cancer, kidney cancer, colorectal cancer, stomach cancer.
But I would say this, when we've looked back and we found that it even causes an increase
in the rate of bladder cancer in terms of Zantac users.
We know from our work in Valsartan where it caused NDMA to break down inside of the body.
That breast cancer, you just wouldn't see that in the animal studies, dietary studies,
occupational studies as much.
So if it, if it causes that and an increased risk, then I think all cancers are on the
table at this point that NDMA from Zantac may cause any type of cancer.
Now, I can hear it in trial, GlaxoSmithKline says, gee, we voluntarily pulled it off the
market.
Truth is when should they have known and put this relationship together and not put any
more people at risk?
As you look at the facts of this case, when should that have been done?
Clearly in the 1980s.
They were, they were also warned internally that this should at least, at the very least,
it should be marketed with a warning to not take Zantac at the same time as eating, especially
with a high nitrate diet, but they did the exact opposite.
Their campaign was to show that you could take Zantac at the same time as a high nitrate
diet so that you wouldn't have the heartburn and you would be able to eat whatever diet
you want it to.
Clearly against what their own internal scientists were telling them.
So, in about 30 seconds, what are their defenses right now?
What are they saying?
What are the, I mean obviously they know this is a multibillion-dollar problem for them.
I mean, because just the call, just the calls that you're getting from people, they're staggering
numbers, aren't they?
Very staggering numbers.
I mean, at this point, you know, we have thousands of clients already internally, but if I look
at the scope of this problem, I mean, Zantac was the most popular pill on the, on the market
back in the 1990s and still popularly prescribed, even as you know, 2016 had 15 million users
at that time.
Fifteen million.
It was very, very popular common drug and what we, what we think is that they're going
to be many people who got cancer as a result of taking Zantac.
Yeah, and people think it's like taking aspirin.
There's no problem here, because that's what their doctors think because the doctors haven't
even been educated really about the NDMA relationship.
That's right.
Daniel, give them hell.
This is, this is an ugly, ugly case.
Stay in there and fight them.
Absolutely.
Thanks for joining me.
Okay.
Thank you.