Patients who volunteer for studies that help
drug companies to develop new products are often misled into taking part,
say research ethicists in the latest edition of the British Medical Journal.
The ethicists have called on drug companies to immediately end what
they say is a “cynical use of these studies for marketing purposes”.
When developing new drugs, most pharmaceutical companies carry out open
label extension studies (OLES) which enable them to collect data after
clinical trials have been carried out but before the drug receives final
approval.
Many of the patients who volunteer to take part in these studies have
previously been involved in clinical trials of the product and are often
recruited on the basis that they are helping scientific research.
But researchers investigating OLES estimate that less than four per
cent of these studies were published in scientific journals and found
that many of the trials they looked at were of dubious scientific integrity.
One of the problems cited by Dr Gordon Taylor from the University of
Bath and co-author Professor Paul Wainwright from Kingston University
was that patients volunteering for the trials tend to be a self-selecting
group with those unlikely to benefit from the new group dropping out
following clinical trials.
This means that the sample of people on the study is not fully representative
and provides biased estimates of safety and tolerability which drug companies
can sometimes use in their marketing promotions.
The researchers say that the cynical use of these studies for marketing
purposes only should cease immediately.
They also question the ethics of recruiting patients who were involved
in ‘blind’ trials of a new drug - where they don’t
know if they are receiving the drug or a placebo - as they may decide
to take part in the study because the new drug, or placebo, made them
feel better without ever really knowing which they received.
As many of these studies are carried out whilst clinical trials are
still ongoing, it is not always clear that the new drug is actually an
improvement on existing treatments that are available. Some patients
may be involved in OLES for as much as two years - or even longer in
some cases - having only been involved in clinical trials for a few weeks.
“ Dressing up marketing exercises in the regalia of research
lends them a spurious authority, allowing participants and clinicians
to believe
they are contributing something worthwhile to science, rather than simply
boosting the market share for the relevant pharmaceutical company,”
said
Dr Taylor who is a Council Member of the Association of Research Ethics
Committees.
“ Open label extension studies are used to gather information
about the safety and tolerability of the new drug in the long term and
through
day to day use, but less than four per cent of these trials are ever
published.
_ We are not suggesting that all
studies are necessarily unscientific or unethical, but it is our experience
that a considerable number of
studies raise significant concerns.
_ These
studies appear to be particularly prone to the pressures of marketing
of good research methodology and research ethics.
_ Although
these studies provide the drug company with valuable marketing information,
such as increasing the number of people taking
the drug before general release and creating a market for it, the value
of these studies to science is highly questionable.”
Where OLES can be useful, they argue, is in giving patients access to
beneficial drugs when no suitable alternative is available. However,
they say that this ‘compassionate prescribing’ of new drugs
should not be facilitated through research studies.
The researchers are now calling for sweeping changes to the ethical
review of OLES.
“ Some of the problems with these studies could be resolved
by letting patients know whether they have been receiving the new drug
or
a placebo in phase three of the clinical trial,”
said Dr Taylor
who works in the University’s Research and Development Support
Unit in the School for Health.
“ This will make sure that they can make a decision on whether
to continue in the open label extension study based on their experiences
from the trial.
_ If these studies are to
go ahead under the name of research, then there should be a much more
rigorous application of scientific principles
in their design and implementation that will allow for variations in
samples and other areas.
_ Compassionate
use of new drugs should not be undertaken through research studies and
another licensing method should be sought instead.
The cynical use of these studies for marketing purposes only should cease
immediately.”
The researchers were given exclusive access to the confidential records
of the Multi-centre Research Ethics Committee for Wales and discussed
their conclusions with members of the Committee, on which they have both
sat.
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