• Drug safety: Merck’s ‘dodgeball’ Drug safety: Merck’s ‘dodgeball’ St. Louis Post-Dispatch — August 23, 2005 All drugs carry risks. The trick for doctors is to weigh them against those of another potential treatment, and the risk of doing nothing.
• Drug safety: Merck’s ‘dodgeball’
Drug safety: Merck’s ‘dodgeball’
St. Louis Post-Dispatch — August 23, 2005
All drugs carry risks. The trick for doctors is to weigh them against those of another potential treatment, and the risk of doing nothing.
When drug makers distort or withhold critical data from doctors and then build patient demand through advertising, the job of accurately weighing risks itself becomes risky.
That’s the lesson of last week’s huge court judgment against Merck & Co., makers of the arthritis drug Vioxx. A jury awarded $253.5 million to the widow of a Texas man who died after taking the drug.
Merck says it isn’t responsible for the death of 59-year-old Robert C. Ernst in 2001. It says it will appeal. Even before an appeal, the $229 million in punitive damages will be reduced. Texas law caps punitive damages at $1.6 million, leaving a total award of no more than $26.1 million.
But the issues raised in the Vioxx case go far beyond the circumstances of Mr. Ernst’s death and the size of the judgment. Vioxx was among the most heavily advertised prescription medicines. It belongs to a class of drugs called COX2 inhibitors that includes Bextra, which, like Vioxx, has been pulled off the market.
In some individual patients, these drugs worked well. But over all, medical studies show they offered no more relief than older drugs such as ibuprofen. They did, however, increase the risk that some patients would suffer heart attack and stroke.
Merck was aware of Vioxx’s increased potential to cause heart attacks before it began marketing the drug. Had the drug maker owned up to those risks sooner, doctors could have limited their use to the handful of patients most likely to benefit.
Instead, Merck, like other drug makers, urged consumers to “ask your doctor” about a prescription. Meanwhile, Merck also was marketing its drug to physicians, assuaging their anxiety about side effects.
The Texas jurors saw a Merck sales training video in which “detailers,” who meet with doctors to tout the company’s drugs, were told Vioxx didn’t increase the risk of heart attacks and taught to deflect questions about high blood pressure, another risk. Sales people played a game called “Dodgeball,” designed to help them field questions from doctors, and, in effect, quiet doctors’ fears about cardiac risks.
The Texas jury didn’t pull that $229 million punitive damages figure out of thin air. According to an internal memo written in 2001, that’s the amount of extra profit the company estimated it could make if it could delay a Food and Drug Administration warning on the label.
Merck did delay that warning.
But in a Texas court room last week, it faced a ball it couldn’t dodge.
