Welcome back to the David Pakman show.
It's great to welcome to the program today, Katherine Eban, who is an investigative journalist
and Fortune magazine
contributor, as well as the author of bottle of lies, the inside story of the generic drug.
Boom.
Catherine, so great to talk to you today.
Thank you so much for having me on the show.
So generic drugs is an issue that relates to intellectual property.
It relates to FDA regulation, it relates to the medical world.
I mean, there's so many different areas that are relevant to talking about generic drugs,
but I, I guess to begin with, how far back does the concept of a generic go?
Well, I mean, it really goes all the way back to, uh, probably the 1920s, 1930s.
But the idea that, um, you could, you could basically be a company that breaks down a
brand name drug and tries to remake version of it is a very old concept
in the sort of modern generic drug world.
When we look at generic alternatives to name brand drugs, many people believe that it is
down to the finest level, the exact same thing as the brand name, except without the brand
name.
It turns out that, that that's not always true and it's in fact often not true in ways
that are sort of concerning and dangerous.
Talk a little bit about that,
right.
Well, it's actually almost never true.
So a generics are not identical copies.
They are versions of brand name drugs and the FDA recognizes that they're not identical
because they give a range, uh, that the generic can fall into in terms of the dissolution
of the drug in the blood.
So under the best of circumstances, uh, it, the generic is similar but not identical.
Um, they may have different active dick, different additional ingredients, different time release
mechanism.
They're made in different factories, uh, avail, dissolve differently in the body.
Uh, but where it really gets dangerous.
Uh, and what I document in my book bottle of lies is the ways in which a generic drug
manufacturing plants on many of which operate overseas are actually committing fraud and
submitting fake data to get approval from the FDA to sell drugs.
Right.
So there's sort of two layers to this.
One is, is there even the expectation or belief that the generic is in practical terms, the
same thing as the name brand drug.
Then separately from that, there's the question of oversight and accuracy as to whether the
generic is even what it purports to be.
And it seems as though both of these are issues that are happening at the same time.
Yeah.
Right.
I mean, the, the idea of the generic as a version a and not an identical copy is accepted
and actually acceptable.
And for many, many drugs, uh, aversion is fine, although there are some drugs were really
precise, dosing is required and those can be a problem.
But the, I think the greater risk for American consumers is that the FDA is not adequately
policing these manufacturing plants overseas.
And essentially accepting the data that these companies are submitting as accurate a when
they are not.
And it's not always, I mean, so we can, there are a number of criticisms of the FDA, many
of which I've made on this program.
But is this a limitation in terms of the standards that are being applied to generics?
Is this something that the FDA is choosing not to do, or is it something that it is,
at least in some cases unable to do?
Huh?
Well, I think the two are somewhat connected, but basically the FDA is a agency that because
of globalization was suddenly required to police manufacturing plants all over the world.
And it essentially acknowledges the difficulty of this because for us, plants, when he inspects,
they just, the inspectors arrive on an unannounced and stay as long as is needed.
But because of the complex logistics of overseas inspections, the FDA announces that it's arriving
to these plants, gives them weeks and sometimes months of advanced notice that they're coming.
So my investigation reveals a, they will send in the plants, will send in data fabrication
teams to alter documents, invent documents, uh, backdate documents and these are all,
you know, quality data quality documents that speak to, uh, whether the drug is bio equivalent,
whether it's got impurities in it or not.
Um, all kinds of issues that are critical to have the drug functions.
When we think about this, there might be people depending on their health circumstances, who
here is talking about this and they go to Advil versus the cvs generic equivalent for
example.
But there are other people who may be in situations where they are actually using generic alternatives
to very, very expensive name brand drugs depending on the, the medical conditions that they may
have.
Does your investigation suggests that the same issues exist to the same degree with
both the Advil generics and the really expensive drugs for, for less common conditions?
Or is it more one versus the other?
It's actually both.
So, just to give you an example in the book, I follow these cardiologists from the Cleveland
Clinic who realize that when their patients were getting switched to certain generics,
um, they were initially stable and then they were no longer stable and even, uh, they found
that heart transplant patients were suffering organ rejection when they were switched to
certain Indian generics.
So there is a, uh, that's generic drugs that were manufactured in India.
Um, so there's, you know, life threatening dangers here.
Um, my book focuses less on over the counter drugs, but you know, what consumers should
know is that the drug store brands say Duane Reed, cvs, the drug store chains are contracting
with the lowest cost Indian manufacturers to make those over the counter drugs.
And those plants are really, uh, audited and inspected infrequently.
So there is a quality issue there as well.
So, I mean, having dug into this and investigated it for the period of time that you did to,
to write the book is your takeaway that there's just too much risk with any generic and that
patients should be doing everything they can to get their insurance to cover the name brand.
Because we'll talk about the sort of practical limitations of that.
I mean, are you, are you, did you come away that concerned where you would just want the
name brand of any drug that you're taking?
Um, I would say two things about that.
I came away extremely concerned and I interviewed plenty of FDA investigators who themselves
would not take the drugs made in the plants that they were inspecting.
Hmm.
Uh, but that said, I also recognize cost is a serious reality and it is for me as well.
So, um, what I do is I often ask my pharmacist to switch from one generic, which I don't
trust to another generic made by a different company that I might trust more.
That's it.
Yeah.
It's knowable.
Which brands, generics are, are more or less is trustworthy even the right word?
Hmm.
Um, it is a knowable thing.
Now the problem is do you have to be an investigative journalist who's looked into this for 10 years
to know it in order to help consumers, I have put information on my website, which is Catherine
even.com.
Uh, and so there is information about steps that they can take to try to figure out, um,
whether they're generic is trustworthy or not and what the options are if they determine
that they want to switch.
Um, you know, it is a bit of a maze.
I'm not going to be, you know, kind of sugarcoat that.
I think what's really needed is congressional action here to fix the problems that I've
exposed.
But in lieu of that, I think there are certain steps that consumers can take.
There's also something called an authorized generic.
So that is a generic where the brand company has made a contract with a generic company
handed over it's recipe.
Um, and the generic company is making the drug under a contract so it's actually closer
to the brand.
And sometimes those authorized generics are actually manufactured in the very same plants
as the brand name drug.
What, what?
You know a lot of people who have dealt with insurance companies, no, is that depending
on the coverage that you have and depending on where you get your insurance, whether an
individual marketplace, as a self employed person or through a work connected insurance
plan, there are all sorts of complex rules about what your insurance will or will not
cover when it comes to prescription medications.
And doctors certainly have the ability to put no substitution on prescriptions, which
collectively tells the pharmacy that a named brand is what should be provided.
But that does not guarantee that runs health insurance is going to cover the name brand
at the same price that the generic would be covered.
So this is, I mean this is really complicated stuff, particularly for people who, who require
medications that are extremely,
yeah, absolutely.
This is not simple and you're quite right that even with the do not substitute, there's
no guarantee that the insurance company will cover a brand when a generic is available.
Can you talk a little bit about, I mean obviously there are a number of different types of concerns
there.
There's straight up safety concerns, right?
Upside of Beck's that one could experience experienced adverse reactions.
There's also the concern of just a drug that in June it's generic version is less potent
or may not achieve the same results as the name brand.
How would you sort of put percentages on those two concerns and others that may exist as
a general rule?
When we talk about ways in which the generics may be suboptimal?
Right?
So I don't know that I can offer percentages.
What I can say is that even if the generics are fine, there is an issue for what are called
narrow therapeutic index drugs.
And so those are drugs that require really precise dosing and the doctors who prescribed
those, so it's cardiologists, psychiatrists, endocrinologist, they are, um, familiar with
this as a problem and they have raised questions about whether the FDA standards, um, are narrow
enough to make, to ensure that the generics are clinically equivalent to the brand.
So that's like in one basket of concerns.
Um, unfortunately with this other basket, um, there is really widespread fraud in the
overseas manufacturing plants that are making the majority of our generics.
So just as an example, um, I feature in the book an Fda investigator named Peter Baker
who became exceptionally good at finding data fraud in these plants.
And over five years he investigated 86 plants in India and China and found some element
of data fraud or data deception in about four fifths of those plants.
So a stunning number.
Yeah, it really is.
Yeah, absolutely.
So, I mean, these are, these are plants that are doing everything from using the brand
name drugs, uh, to run tests and take that data and submit it to the FDA as though it
was their own data from their own drugs.
So completely supplanting the data, inventing documents and steaming them in rooms overnight
to make them look old.
Um, you know, completely just discarding critical manufacturing documents where FDA investigators
have dug them out of dumpsters when documents are supposed to be retained.
So, you know, these are really, um, major lapses in what are called good manufacturing
practices that these plants have to follow.
I mean, some plants have, even when you have a sterile manufacturing plant, and that's
very serious, they have to follow a sort of a septic regulations.
Um, they have literally invented there sterility data.
They're supposed to test air water surfaces to make sure they're free of microbial contaminants
and they've just invented that data.
They're not really running the tests.
Uh, so that's the kind of things that are going on in these plants.
Absolutely, absolutely stunning.
Um, make sure to check out Katherine's book, bottle of lies, the inside story of the generic
drug.
Boom.
We have been speaking with the book's author, Katherine Eban.
Yeah.
Who is an investigative journalist and Fortune magazine contributor.
Katherine, so great to talk to you about this.
Great to talk to you.
Thank you so much.
The David Pakman show@davidpakman.com