Tuesday, December 16, 2008

Phony Patients may Avert Adverse Drug Events

On May 20, 1999 Rofecoxib, better known as “Vioxx,” was approved as safe and effective by the Food and Drug Administration (FDA), on September 30, 2004, the manufacturer voluntarily recalled the drug from the market because of concerns of increased risk of heart attack and stroke.

Clinical trials or drug testing, a pharmaceutical service, is complex. And while the criticism of the US FDA over monitoring of product safety continues, there may already exist solutions that may help the federal agency to better prevent similar debacles from recurring.

The Virtual Patient Platform

One such predictive computer model of human physiology is known as the Cardiovascular PhysioLab(R). Developed by Entelos, this platform can aid in drug discovery and development by offering a comprehensive large-scale computer simulation of cholesterol regulation, atherogenesis, and cardiovascular risk.

In fact, it may also help evaluate combination therapies, identify and interpret biomarker patterns, and predict a drug's long-term clinical efficacy in managing cholesterol, atherosclerosis, and heart disease.

Heart disease is the leading cause of death for both women and men in the United States. For instance, in 2002, 696,947 people died of heart disease, about half of them women. This is a big number because it made up for 29% of all U.S. deaths.

Now, while these man-made patients might serve as a powerful and innovative means towards diagnosis, treatment, monitoring and prevention of complex, chronic diseases, modern controlled clinical trials are still the best way for evaluating safety and efficacy of drugs, according to pharmaceutical service industry experts.

Nevertheless, technology such as this which enables a broad range of "virtual patients" to be tried for different drugs, does seem to make the job of drug development easy and safe. Perhaps with time as the technology advances, it may include many more functions, reducing dependence on human subjects. Making it even safer.

And to the FDA, it might provide an invaluable tool to better monitor ongoing cardiovascular trials before their submission for approval, and also help it to determine possible adverse events in advance. Possibly preventing another drug debacle like the one from the past.

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