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.
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