Visiongain Report Notes Increased Emphasis on Drug Safety Through Pharmacovigilance

San Francisco, CA and London, UK; 27 July 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.

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
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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.

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