Introduction - Uppsala Monitoring Centre

to restrict or withdraw a drug.
‘366. The adverse drug reactions reported in the clinical trials that are considered in
the medicines licensing process typically prove unreliable as a guide to routine
clinical practice. Moreover, the adverse effects that may be linked to stopping
treatment are insufficiently investigated.
371. After a drug is withdrawn for health reasons, there are often a number of
questions in the public mind, not least because such cases typically leave behind
victims injured by the drug or bereaved relatives of people who suffered fatal
reactions to the drug, as well as people who are denied access to a drug they
may have found beneficial. A public inquiry could answer such questions as:
should the safety problems have been better predicted from the pre-market
testing data? Did the regulators get full and appropriate safety and efficacy data
from the manufacturer? Was the right judgement made in balancing the risks and
benefits of the drug? Could the health problem with the drug have been identified
and acted upon earlier? Could and should the drug have been withdrawn earlier?
Was sufficient consideration given to the continued provision of the drug for
patients who uniquely benefited from it after withdrawal? Such a public inquiry
could not only provide understanding and a sense of justice for the public, but
equally importantly would ensure that the drug regulatory agency can learn
effectively from mistakes and avoid them in the future. We recommend that there
should be a public inquiry whenever a drug is withdrawn on health grounds.’
(http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/4212.
htm) Accessed 7 th September 2001). Can we presume that the same situation
existed in the period before 1961?
Many of the problems concerning drug safety illustrated in this book still continue
post 1960:
Adulteration, e.g. Chinese Traditional Medicine
Reluctance of pharmaceutical companies to admit to ADRs, e.g. Vioxx
New types of ADRs, e.g. progressive multifocal leukoencephalopathy
Causality: Clinical (very subjective) or epidemiological (poor control groups)
Assessing possible risk factors, e.g. pharmacogenetics
In many different contexts we hear the adage ‘safety is paramount’, but rarely the
proviso ‘as long as it doesn’t cost too much’. Complete drug safety is an impossible
aim; each country or political party will decide what they can afford and what their
priorities are, and these will change with time and circumstance. We cannot judge
history, we were not there and, therefore, we cannot appreciate all the factors that
might have influenced them.