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“The manipulation of
clinical medicine trials
is so common and so
serious that reports on
these studies should
only be viewed as advertisements for
medical drugs,” says Professor Peter
C.Gøtzsche,directoroftheNordic
Cochrane Centre at Rigshospitalet in
Copenhagen. It’s a statement that is
sure to make some enemies for him.
Becauseforamedicaldoctorthese
areextremelyharshwords,andthey
are being directed not only against
the pharmaceutical industry but also
against all doctors and researchers
whoremainsilentonthistopic.The
truth is, that’s what most doctors do.
Butwhatdoesthatmeanforus,as
their patients?
“On the one hand you have studies
that are mostly financed and carried out
by the manufacturers and these tend to
be overly optimistic. And on the other
handyouhavethosestudiesthatdonot
provide the hoped-for results, and
those studies tend to be published
much less frequently,”explains
Professor Gerd Antes of the
Albert Ludwigs University of
Freiburg. It turns out that the
pharmaceutical companies
don’tevenhaveanyneedto
invent or falsify findings—
it’s enough to weigh facts
differentlyortoleavethem
out entirely. “Seemingly smalldifferences can amount to billions of
dollars on the world market,” explains
Gøtzsche. In any case, the principle
seemsfairlysimple:Whoeverhasthe
financial resources also determines
theresults.Thathasbeenconfirmed
by random sampling conducted by
Cochrane. Depending on the study in
question, Cochrane research shows
between50and61%offundeddrug
studies financed by pharmaceuticalcompanies were influenced in favor
of the companies. But manipulated
studies do not stand in the way of
drugs being approved—since to thisARE DRUG
STUDIES
MANIPULATED?
day, “There are no cross-disciplinary
standards in place for the peer review
process and just as few measurable
quality criteria,” observes Flaminio
Squazzoni, an assistant professor of
economic sociology at the University
of Brescia in Italy.
The real scandal, however, is that
this is no secret. Tens of thousands of
these manipulated studies have been
exposed — revealed, for example, by the
37,000 researchers working for Cochrane
who publish their revelations in reputable
trade publications and medical journals.
Doctors should know about it. They
have a tremendous responsibility to
their patients—people who expect
their doctor to at least be informed
and up-to-date regarding the most
signifi cant medical developments,
particularly when it comes to drugs
that the doctor actually prescribes.
But the past shows: Many medicines
are still being prescribed, though the
available studies no longer support
their use. One example is provided
by the PSA test for early detection of
prostate cancer. Even though studies
now advise against this test, and
even pathologist Richard Ablin,
who developed the test, has
spoken out on its misuse
and unreliability, doctors
still order it. The same
is true of the calmative
diazepam (Valium). It
sounds insane, but
although it has been
known for 30 years
that the substance
is just as addictive as
heroin, it continues to
be prescribed.“The pharmaceutical industry
has monopolized clinical
studies for marketing purposes.
This troubling state of affairs
leads to clinical research
ad absurdum.”
PROFESSOR PETER C. GØTZSCHE
DIRECTOR OF THE NORDIC COCHRANE CENTRE