Is more money the answer to improved drug safety monitoring?

Researchers at Duke University and the University of North Carolina at Chapel Hill estimate that in 2003 the top 20 pharmaceutical manufacturers spent a total of $800 million, or 0.3 % of sales, on dr

By Editor on Mar 9, 2006

Researchers at Duke University and the University of North Carolina at Chapel Hill estimate that in 2003 the top 20 pharmaceutical manufacturers spent a total of $800 million, or 0.3 % of sales, on drug safety monitoring following FDA approval. The group says pharma companies spent 15.6 % of sales on research and development in the same year.

The study resulted from a meeting in 2002 organized by the Center for Education & Research on Therapeutics (CERTS) that included consumers, the pharma industry, universities, government and health professional societies.

Even before the Vioxx withdrawal, there was broad interest in improving the system for monitoring drug safety, says David Ridley, assistant professor at Duke's Fuqua School of Business and lead author of the study. The Vioxx withdrawal increased that momentum.

The research, which was sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Agency for Healthcare Research and Quality, was published in the March 9 issue of the journal Health Affairs.

Now that we have established how much is spent monitoring drug safety, the next question is whether more should be spent, says Ridley. My sense is that we should not necessarily spend more on the same system, but create complementary systems to improve safety.

Kevin Schulman, director of Fuqua's Health Sector Management program and one of the study's authors, says it is important to monitor the safety of marketed pharmaceuticals because clinical trials can'st detect rare side effects.

Clinical trials are not designed to detect events that occur in as few as one in 1,000 patients, says Schulman. Many risks and adverse effects cannot be observed until after a treatment has been approved and used by a large and diverse population. That is why post-approval monitoring is key to protecting patient health.

The study was conducted via a web-based survey that 25 large pharmaceutical companies were invited to complete. Eleven of the 25 companies completed the survey; those 11 companies's sales accounted for 71 percent of sales by the top 20 pharmaceutical manufacturers in 2003.

According to the researchers, companies each spent an average of $56 million for post-approval safety, in a year during which their mean sales were $17 billion per company. And the group reports the U.S. government budgeted $22.1 million for the Office of Drug Safety in the FDA's Center for Drug Evaluation and Research -- less than the mean safety spending by an individual firm.

With greater funding from manufacturers and/or the FDA, more post-approval research could be conducted to follow up on pre-approval concerns and investigate new signals identified by surveillance, says Judith Kramer, chief medical officer of the Duke Clinical Research Institute and one of the study's authors.

Throwing more money at a problem is the easy solution, finding a system that works is the real challenge. And no doubt creating a system that works well will cost more, but the improved health it would bring to patients and the industry's future would make it money well spent.