Merck Predicted Vioxx Sales Would Plummet with Warning Label

Merck & Co. testified that predicting a warning label about the health risks of its Vioxx painkiller could cut annual sales by half. This estimate was made in 2001 while Merck was fighting regulations to force disclosure of Vioxx's health risks on the product label. The company's president, David Anstice, confirmed that a 50% drop in sales would be a significant downside.

Key Takeaways:

• Merck & Co. estimated that a warning label about the health risks of Vioxx could cut annual sales by $2.5 billion, or half of the total, in 2001.
• The company was fighting efforts by regulators to force disclosure of Vioxx's health risks in the warning section of the product label.
• Merck presented data to an advisory committee of outside physicians and scientists, but six of the ten members had actual or potential conflicts of interest.
• One of the physicians, James H. Williams Jr., received $53,157 in speaking fees from Merck.
• Another physician, Byron Cryor, received $174,428 in fees from Merck over several years.
• Merck's former top scientist, Edward Scolnick, expressed disdain for FDA regulators and attempted to influence the label change.
• Scolnick stated in an email that he would visit FDA scientist Janet Woodcock if Merck competitor Pfizer Inc. got a better label change for its similar painkiller, Celebrex.

Statistics:

• $2.5 billion: estimated annual sales drop if warning label is implemented
• 50%: estimated drop in sales compared to the previous year
• 5,000: number of lawsuits against Merck related to Vioxx
• 3: ranking of Merck as a U.S. drug maker
• 60: age of Vioxx user Frederick Humeston
• 2001: year in which Humeston suffered a heart attack
• 2002: year in which Merck persuaded the FDA to allow health data in the "precautions" section of the label

Sources:

• Bloomberg News
• Merck & Co. internal documents
• U.S. Food and Drug Administration (FDA)
• Pfizer Inc.
• Celebrex