Science

This picture of our budding scientist Maya says it all.

Speaking of science, celecoxib (Celebrex^®), a drug in the class known as COX-2 inhibitors, has been in the news this week following a report from a Food and Drug Administration (FDA) panel saying what many of us believed was true based on analyses of available data over ten years ago: celecoxib poses no greater risk for causing heart attacks and strokes than two other widely used pain relievers, ibuprofen (Advil^®) and naproxen (Aleve^®). It is important to note that the reason why this is of such great importance is that the COX-2 inhibitors work quite well for many people with chronic pain.

In September 2004, the FDA withdrew its approval for Merck’s COX-2 inhibitor rofecoxib (Vioxx^®) due to increasing evidence that it caused heart attacks and strokes. This resulted in significant concern over the safety of two other drugs in the same class, celecoxib and valdecoxib (Bextra^®), both developed and marketed by Pfizer. A three-day special panel met in February of 2005 to examine the data on these two Pfizer drugs. Valdecoxib was removed from the market, but in the absence of what they considered to be definitive data, the panel allowed celecoxib to remain on the market with plans to conduct a large, long-term study of celecoxib, ibuprofen, and naproxen. Over ten years later, the results of that study are the subject of these current reports.

FDA Panel Affirms Safety Of Painkiller Celebrex

It was quite a tumultuous six months for me. Joshua had just been born and we were trying to get down to Maryland (where they were then living) as much as possible, but the work load of leading the statistical team for this project was quite intense and clearly very important. Fortunately, I do not believe Joshua was aware that we did not see him as much as we would have liked during that period. Still, he is a big part of my memory of those seemingly endless long days of sorting out the information we had available to us. It has been almost fifteen years now, and at last we have a definitive answer.

I received a Pfizer Global Research and Development Achievement Award for this work, which hangs on the wall near my computer desk at home to this very day. I will always look at that period as a highlight of my career at Pfizer.

Love,

Rebecca