Advertisement
In Issue 1071 (on stands now), contributing editor Ben Wallace-Wells takes a close look at the marketing of Zyprexa, a drug created to treat schizophrenia that wound up being used on depressed moms and misbehaving kids in "Bitter Pill." Wallace-Wells, who also wrote "How American Lost the War on Drugs" for the magazine, spoke with Rolling Stone about breaking down Big Pharma for his most recent story:
How did you start reporting "Bitter
Pill"?
My girlfriend at the time, now my wife, was a medical student
working with patients at a psychiatric hospital. I was struck by
the stories that she'd come home with every night. I got the sense
through her of the density of the illnesses and the imperfection of
the drugs. So, I thought that that I could try to explain the ways
in which the pharmaceutical industry was trying to solve a problem
and the way in which its solutions were coming up short. As I was
looking at all that, it happened that Eli Lilly was sued by the
state of Alaska for overstaying the benefits of Zyprexa and for
marketing it off-label. As I began to try to make sense of the case
you just felt this awesome story looming up, where you went from a
drug that had a very tiny population of users and a very specific
population of users and ended up being blown up into this absolute
blockbuster super drug. I was fascinated by the scientific and
marketing techniques and manipulations that had to happen for that
to take place.
Isn't what the pharma companies were doing due to the
natural function of capitalism to a certain degree? Isn't this just
how corporations behave? Should we be shocked by
this?
I don't know that we should be shocked by it, but I think we should be disturbed. The way the pharmaceutical industry in particular operates for profit, it's always sort of running up against the point of illegality. This is particularly pronounced when it comes to this issue of off-label use. The FDA approves drugs for very particular indications. Doctors are permitted to prescribe drugs for other indications probably for good reasons, but pharmaceutical companies are not permitted to push these drugs for uses that the FDA has not approved them for. But often, particularly with psychiatric illnesses, there's this huge profit to be made in off-label use. You see it here where a drug for schizophrenia, which is a very small market — a few hundred million dollars a year — gets blown up into a many-billion dollar market. It's kind of pushing that line, and going into that gray area and, in some cases, overstepping that line. And it's not always possible for the federal government to watch the companies as closely as we'd like. The safeguards that exist for monitoring them are, in some ways, faulty.
And under the Bush Administration, oversight in every
area has been stripped away. Would this case have happened 10 years
ago?
That's one of the fascinating things about this story: You see the
rot that comes with the Bush Administration very vividly. The
numbers of warning letters that the FDA sends out to companies if
they're overstepping just drops. And the number of staff the FDA
has to devote to policing these violations is slashed. There's been
a dramatic erosion of the FDA's ability to monitor drugs. And you
end up with scandals and tens of thousands of people living with
diabetes who wouldn't otherwise have diabetes if they hadn't been
put on these drugs, that scientists hadn't properly checked out and
whose marketing was over the line. That's the very real kind of
real identifiable human cost of the bureaucratic rot that we have
seen over the last decade.
Advertisement
What surprised you reporting this story?
What was striking about it was how regular this was for them, how normal. This is one of the biggest scandals in recent pharmaceutical history. Eli has already paid 2.6 billion dollars in fines and to settle lawsuits — just an enormous amount of money. And yet, it's a 3 or 4 billion dollar a year drug. What's most disturbing about this whole story is that as bad as all this press has been and though Eli have settled investigations by federal prosecutors and claims by people who have been hurt by using this drug for huge amounts of money, they still came out way ahead.
It becomes just part of their cost of doing
business.
Yeah. One of the doctors I talked to who is an expert in this case
said to me, "We've seen this with a number of drugs." There's a
10-year patent protection companies get when they introduce a drug.
Usually, around year two or three, there'll be a lot of reports of
problems with a particular drug. Obviously, this doesn't happen
with every drug, but it's a consistent pattern with those drugs
where something's gone wrong. For four or five years the company
will fight tooth-and-nail with any scientists who say that they've
cooked the books. They'll be very antagonistic to reporters who ask
questions and then, around year 10 you start seeing a lot more
accommodations. They start going to researchers and saying, "Well,
maybe you guys were right all along." They'll start settling suits,
and they'll start saying to reporters, "Yeah, maybe we did
something wrong." So, right now, Eli Lilly is right on the cusp of
that and they're beginning to settle suits. The difference in part
is that if you're on year three of a patent, you're still hoping to
goose most of your profits out of it. By year eight, there's not
that much left, so you're much more open to acknowledging
difficulties with the drug. There's this arc that repeats itself
again and again.
Do the doctors and psychiatrists who prescribe these
bear some responsibility?
I think they do. One of the things that you realize when you make
your way through a story like this is that there are hundreds of
studies that are out there that say completely contradictory things
about a particular drug. Many studies have been sponsored by the
industry and many others have been conducted by independent
researchers. For a particular physician, particularly a physician
who is not in the practice of dealing with schizophrenia drugs, to
make his way all through that material, with all of these very
strongly stated but completely conflicting claims is a really
difficult task. So, at some level, it's a lot to expect of
particular physicians to be able to sort all this out. But the way
that a lot of physicians seem to deal with it is to just sort of
trust the drug companies a little more than is warranted. What seem
so ridiculous to us is what pharmaceutical/drug reps do, and we
deal with this a little bit in the story, like leaving muffins with
doctors or leaving pens with the name of their drug really work. I
think that you'd prefer a medical profession that was less
susceptible to such cheap pay-offs. You wish that the sales pitches
were a little less successful and that's kind of a depressing part
of it and that the doctors were a little more skeptical and a
little more circumspect.
Related Stories: