Biologically Determined is always in
search of a challenge, and so in this post we are going to try and get you
animated about publication bias. We will also try to explain why so many
scientists already are, and why they have formed movements such as All Trials
that try to address this bias.
Scientists, paid for by private firms,
carry out trials and studies of medicines and therapies and the results are
published in peer-reviewed journals. All of this is intended to ensure that
a drug is safe and effective before it can be sold. For many drugs, the placebo
effect is large relative to the actual effect, so multiple studies are
necessary to show that a drug works. If a firm can carry out many studies
and publish only the positive results, it can market drugs that may not be safe
or effective. The pharmaceutical industry has been doing just this.
The All Trials campaign is a heartening
example of individual scientists standing up for integrity. The movement
appears to be gathering momentum, with a committee recently assembled
by the British House of Commons recently endorsing universal trial registration
and describing the current lack of transparency as
"unacceptable".
The classic example of publication bias
concerns the drug Lorcainide. Lorcainide was trialled in 1980 to treat
arrhythmia in heart attack patients. Of the 50 people given the drug in the
initial trial, 10 died, compared to only one in the control group – a huge
increase in mortality. Lorcainide was
discontinued and the results were left unpublished. However other companies
developed similar drugs over the following decade. These arrhythmia drugs, like
Lorcainide, dramatically increased the mortality rate among heart attack
patients. An estimated 100 000 unnecessary deaths occurred before these
fatalities were linked to the arrhythmia drugs. If the results of the
Lorcainide trial had been made public by law, many lives could have been saved.
Publication bias in recent years has also fueled (possibly unnecessary)
controversy over the efficacy of both the antidepressant Reboxetine and the
antiviral Tamiflu, as
the companies involved refuse to publish all of their data.
Despite their embarrassing track
record, representatives of pharmaceutical companies claim that they are "firmly committed to enhancing public health" and
are doing nothing wrong. The reality is that pharmaceutical companies are
legally mandated to generate value for their shareholders. They are ‘institutionalised
psychopaths’ - charged with maximising profit. Expecting them to act in the
patients' interest, in the absence of regulation, is ridiculous. If pharmaceutical
companies can exaggerate the efficacy of their drugs by cherry picking the
results they publish, they will. Strict regulation in this case the only
remaining option - other means have already failed to
produce transparency.
Considering this, news that pharmaceutical
companies are exerting pressure on regulators to let them continue shouldn't
come as a surprise. A leak published in a
British newspaper, The Guardian, reveals some of the underhand measures
undertaken by pharmaceutical companies to exert this pressure. They intend to 'mobilise'
patient groups to oppose efforts in order to make all clinical trials public.
Patient groups are concerned that efforts to make data public will violate
their privacy as patients. This concern is a red herring - no campaign
anywhere calls for individual patient data to be released - only anonymised data.
Protests that companies' interests would be prohibitively damaged by the
release of information are also false - GlaxoSmithKline has demonstrated this
by consenting to publish even more than the All Trials campaign demands.
Opponents of the All Trials
campaign would like to portray it as a further burden on an
already over-regulated industry. It can be reasonably argued
that the drugs market is already over-regulated, causing needless delays and expense.
However bad regulation is not a solution to over-regulation.
Imagine a world in which
pharmaceutical companies are required to publish all the evidence relevant to
their customer’s health. In this world, how many people would want the system
to be changed to allow companies to be able to hide some of this evidence? The current situation only seems reasonable because it is the
status quo.
What the industry fails to
understand or account for with their resistance to the All Trials campaign and
other efforts is that trust, once lost, is difficult to regain. Cases like the
Hindenburg disaster or Chernobyl illustrate what a powerful effect even a
single incident can have on public trust in a technology. Not enough effort has
been made to underline the importance of credibility in medicine and how pharmaceutical
companies are gambling with it.
