E-DRUG: Access to VigiBase
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International Society of Drug Bulletins (ISDB)
PRESS RELEASE 15 Feb 2012
PHARMACOVIGILANCE DATA: BROADENING ACCESS TO SIGNAL IS A POSITIVE STEP,
BUT ACCESS TO VIGIBASE IS ALSO NEEDED
Public access to Signal: a step into the right direction. The
International Society of Drug Bulletins (ISDB), a worldwide network of
independent drug bulletins, welcomes the World Health Organization
/Uppsala Monitoring Centre's long-awaited decision to give broader access
to Signal, its publication which draws upon data from the large WHO Global
Individual Case Safety Reports (ICSR) database, also known as VigiBase
(a).
The ISDB bulletins that deal with pharmacovigilance issues should benefit
from Signal. But a degree of secrecy might well persist, as the current
procedure gives the opportunity for relevant pharmaceutical companies to
read and comment on SIGNAL texts, prior to publishing and since articles
will continue to be circulated to National Pharmacovigilance Centres prior
to publishing in the WHO Pharmaceuticals Newsletter.
Suspected adverse drug reactions are public scientific data:
public access to VigiBase is urgently needed. Data about adverse effects
suffered by patients cannot be regarded as commercial data that
pharmaceutical companies collect as part of their marketing operations.
Health professionals and patients report suspected adverse drug reactions
in order to help prevent their recurrence and the suffering of other
patients.
Public access to all scientific data is needed to allow for independent
decision-making. For example, rofecoxib (Vioxx®), rosiglitazone
(Avandia®), benfluorex (Mediator®) were finally removed from the market
only because of independent researchers findings, based on analysis of
clinical data and suspected adverse drug reactions. And since thorough
collection of adverse event reports is a critical step in
pharmacovigilance, public access to VigiBase will allow researchers and
independent teams, such as ISDB editors, to make more comprehensive
assessments of drug harms and check at the same time the quality of the
data entered into the database.
In several countries around the world, databases of suspected adverse drug
reactions have already been publicly accessible for a number of years (b).
The World Health Organization is responsible for providing leadership on
global health matters (www.who.int). We therefore request that VigiBase
be made publicly accessible by the end of 2012.
The International Society of Drug Bulletins