Photo of pills

Amanda’s Absence:
Should Vioxx Be Kept Off the Market?

by
Dan Johnson
Department of Biology
Wake Forest University

Part I—Withdrawals

“Amanda missed bio lab again this week.”

This was not what Dr. Sharpe had expected to hear when his teaching assistant knocked on his door late one Tuesday afternoon in March. Amanda was an exceptional student. She had been born with Type III osteogenesis imperfecta, a painful and debilitating condition in which bones break and deform easily. Despite her condition, Amanda had earned top academic honors during high school and came to college on a merit scholarship. Before a month ago, she had never missed a single lecture or lab, but thinking back, Dr. Sharpe could not remember her attending his class for at least a week. Was there something seriously wrong?

The Student Health Center had no information, but a phone call to Dr. Rutter, the Dean of Students, cleared up the mystery. “Amanda has asked to withdraw for this semester for medical reasons. It seems she can’t control her pain anymore, now that Vioxx is off the market.”

Dr. Sharpe remembered the Food and Drug Administration had announced that two pharmaceutical companies were withdrawing Vioxx and Bextra from the market because they caused heart attacks. Both were in the same drug class, the Cox-2 inhibitors. He also vaguely remembered commercials pitching Vioxx to senior citizens for arthritis pain.

Questions

  1. Some prescription drugs may remain on the market 20 years or more. Others are removed shortly after being introduced. Give three to four reasons that a drug might be removed from the market, either by the FDA or its maker. Is every reason true for every drug?
  2. How might the manufacturers have determined that Vioxx increases the risk of heart attack? Based on your answers, when would they have learned this information?
  3. What other facts or information might Dr. Sharpe (or you) want to know about Vioxx? About Amanda’s condition?

Go to Part II—“Press Release”

Date Posted: 10/25/05 nas

Image Credit: Photo © Piotr Łukasik.

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Originally published at http://www.sciencecases.org/vioxx/vioxx.asp

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