firms hiding negative research are unfit to experiment on people
was sued by the New York attorney general for 'illegal and deceptive' reporting
of the risks of its anti-depressant Seroxat. Photograph: Jack Sullivan
pharmaceutical giant has settled a big compensation claim. So why are they
allowed to go on misleading the public?
week the drug company AstraZeneca paid out £125m to settle a class
action. More than 17,500 patients claim the company withheld information
showing that schizophrenia drug quetiapine (tradename Seroquel) can cause
diabetes. So why do companies pay out money before cases get to court?
feature of litigation is that various documents enter the public domain.
This is how we know about the tobacco industry's evil plans to target children,
the fake academic journal that Elsevier created for Merck's marketing department,
and so on.
of the most revealing documents ever to come out of a drug company emerged
from an earlier quetiapine case: an email from John Tumas, publications
manager at AstraZeneca. In it, he helpfully admits that they do everything
I say drug companies do.
allow me to join the fray," Tumas begins, in response to a colleague.
"There has been a precedent set regarding 'cherry picking' of data."
Cherry picking is where you report only flattering data, and ignore or bury
data you don't like. The ears of lawyers prick up at any use of the word
"bury" in relation to drug company data, as it implies something
deliberate, and luckily John uses this word himself. The precedent, he explains,
is "the recent … presentations of cognitive function data from
trial 15 (one of the buried trials)".
15, commissioned by AstraZeneca, patients with schizophrenia who were in
remission were randomly assigned to receive either AstraZeneca's quetiapine,
or a cheap, old-fashioned drug called haloperidol. After a year, the patients
on Seroquel were doing worse: they had more relapses and worse ratings on
various symptom scales. These negative findings were left unpublished: to
use Tumas's word, they were "buried".
in among all these important negative findings, on a few measures of "cognitive
functioning" – an attention task, a verbal memory test –
Seroquel did better. This finding alone was published in a research paper
in 2002. AstraZeneca kept quiet about the fact that patients on Seroquel
had worse outcomes for schizophrenia. The research paper went on to become
a highly influential piece of work, cited by more than 100 academic research
papers. Many researchers can only dream of publishing such a well cited
piece of work.
15 also found that patients on Seroquel gained, on average, 5kg in weight
over a year. This put them at increased risk of diabetes, which is what
AstraZeneca is now paying to settle on (and in any case, a 5kg weight gain
is a serious side-effect in itself).
drugs can do more good than harm overall, but many have serious, common
side-effects. It is especially important that doctors and patients know
all the risks, so that sensible and informed trade-offs can be made.
is the opening of another email in that quetiapine case. Richard Lawrence
writes in an internal memo to colleagues: "Lisa has done a great smoke
and mirrors job" on trial 15.
pharmaceutical industry's behaviour has collapsed into farce. Doctors and
academics – who should feel optimism at working with the drug companies
to develop new treatments – feel nausea instead, knowing that there
are only informal systems to deal with buried data, and these have clearly
the International Committee of Medical Journal Editors put its foot down
and said its journals would only publish trials that were fully registered
before they started, which should make any that went missing much easier
to spot. Several years later, as recorded in this column, fewer than half
of all the trials that the editors published had been adequately registered,
and more than a quarter were not registered at all.
the New York attorney general sued GlaxoSmithKline over its "illegal
and deceptive" reporting of the risks of its anti-depressant paroxetine
(tradename Seroxat), GSK agreed to publish all trial data on a website.
But, several years later, we saw last month that GSK and the Food and Drug
Administration had sat on data showing that rosiglitazone (tradename Avandia)
increased the risk of heart problems.
see why any company withholding data should be allowed to conduct further
experiments on people. I can't see why the state doesn't impose crippling
fines. I hope it's because politicians don't understand the scale of the