“In the first quarter of 2005 we saw an all-time peak in the number of ‘black box warnings’ from regulators,” he adds. “We hope in the interests of physicians and patients that we can get back to normal – and focus on science and facts that have historically led to the discovery and development of important pharmaceutical products which have vastly improved the quality of life for each of us.”

Novartis and other pharmaceutical companies are obliged to establish and maintain comprehensive, worldwide networks to monitor safety of their products. At Novartis the Clinical Safety and Epidemiology function – in collaboration with our local operating companies – is responsible for worldwide safety surveillance; the collection and reporting of safety data according to regulatory requirements of all Novartis investigational and marketed drugs; and for providing medical safety evaluations and epidemiological support for drug development activities.

Surveillance begins during initial stages of development of a new compound (or new formulation of an existing medicine) and is maintained throughout the lifetime of a product. The company’s drug-safety policy applies to all active pharmaceuticals undergoing evaluation or development in any clinical trial in any country – including products sold by third-party licensees, or co-marketed by Novartis and third parties.

Each local country organization in the Novartis group is responsible for overseeing the safety of pharmaceuticals it sells locally, for complying with local regulatory

In yet another initiative, the Novartis Pharmaceuticals Division created a Product Stewardship Board responsible for proactively identifying, assessing and managing any possible product-related risk. Generally, each marketed product is subject to a standard annual review by the Stewardship Board for the first five years following market authorization. Subsequent reviews take place every five years – in addition to any further unscheduled assessments deemed necessary. The process aims to ensure appropriate product information and communications to doctors, patients and authorities.

The Product Stewardship Board reports every quarter to the Pharmaceuticals Division Executive Committee. Both Sandoz and the Consumer Health Division have established similar product stewardship processes.

Vioxx® was withdrawn after studies allegedly demonstrated an increased risk for cardiovascular-related adverse events that some would argue outweighed benefits of use.

Prexige, however, has been approved by regulatory agencies in Brazil and the United Kingdom among other countries.

Evidence-based medicine and unmet medical need were the pivotal factors in the decision by Novartis to launch Prexige despite the troubles facing competing products such as Vioxx® . “We have always believed that Prexige is a well-characterized product with a very positive risk-benefit profile,” Dr. Shannon says.

“Novartis showed in the 18 000-patient TARGET study that Prexige has a better gastrointestinal safety profile – and no significant difference in cardiovascular safety – compared to nonsteroidal anti-inflammatory drugs (NSAID), the standard treatment before introduction of COX-2 inhibitors”, Dr. Shannon adds. “We believe Prexige is an excellent alternative for the right patients – who are at risk for GI bleeds and who are free of any cardiovascular risks.”