Released on = July 14, 2006, 4:32 am

Press Release Author = Visiongain

Industry = Pharmaceuticals

Press Release Summary = SAN FRANCISCO, CA & LONDON, UK, July 14, 2006 -- The global
pharmaceutical market is experiencing regulatory safety changes imposed from a new
source. A more cautions public, particularly in the US, is becoming increasingly
risk averse, and is demanding that the pharmaceutical industry responds accordingly.
An increase in the number of drug withdrawals, including the high profile cases of
Vioxx and antidepressants in adolescents has raised the stakes for the industry. 'I
think the medical profession, as well as the public is saying to the industry,
"Assess and communicate the risks and benefits associated with your drugs more
accurately or we will simply switch back to the older tried and tested products with
known risk," commented visiongain pharmaceutical market analyst Tristan Heath.

Press Release Body = In one day alone, the withdrawal of Vioxx cost Merck $27
billion in lost share value. The continuing court cases will impact Merck's revenues
both directly and indirectly. The size of the patient population that was using
Vioxx made the impact of this drug withdrawal even greater. The FDA and the EMEA
reacted to public and political pressure and drug safety has been propelled to the
top of their agendas.

Although pharmacovigilance may well seem a case of shutting the stable door after
the horse has bolted, it is a very effective means of increasing drug safety. Having
established safety and efficacy to a level that allows the marketing of the drug,
pharmacovigilance then allows assessment of safety information from a considerably
wider group of patients exposed to the drug than is possible during clinical trials.


For a public that is increasingly risk averse, the identification and collation of
valid safety information is a vital step in improving the risk-benefit assessment.
Communicating this information in an appropriate yet effective manner remains a
considerable challenge.

Visiongain's report - Pharmacovigilance - Risk Management in Practice - assesses the
pharmacovigilance practices and anticipated changes to both the US and the EU
systems. An overview of reasons behind current trends in pharmacovigilance and the
opportunities that now exist for companies to utilise new pharmacovigilance
practices are considered.

ENDS
Notes for editors: To receive your complimentary overview of - Product Lifecycle
Management - Please send an email to Sara Peerun sara.peerun@visiongain.com,
telephone Sara on +44 (0) 20 8767 6711 or see www.visiongainintelligence.com. Please
include your full name, title of publication, contact telephone number, email, and
details of where you saw this release. Upon receipt of this information, an overview
will be emailed to you.

Background:
Visiongain is one of the fastest growing and most innovative independent media
companies in Europe today. Based in London, UK, visiongain produce a host of
business-2-business conferences, newsletters, management reports and E-Zines
focusing on the Financial markets, the Pharmaceutical, Telecoms industries and the
Defence sector.

For information on visiongain, please visit www.visiongainintelligence.com


Web Site = http://www.visiongainintelligence.com

Contact Details = Visiongain
4th Floor
BSG House
226-236 City Road
London EC1V 2TT

Tel: +44 (0)20 7336 6100
Fax: +44 (0)20 7549 9932