A top Merck executive yesterday acknowledged the company could have lost as much as $500 million in annual sales if regulators had succeeded in placing an unfavorable warning on the Vioxx product label three years ago.
David Anstice, who headed Merck’s U.S. marketing at the time, admitted an internal memo showed the company feared a huge drop in sales if the Food and Drug Administration won a battle over the Vioxx label.
“Those were important projections,” said Anstice, a slightly built man who spoke in an Australian accent during his third day on the witness stand in Superior Court in Atlantic City.
The battle with the FDA lasted for two years following a 2000 study that found an unexpectedly high rate of heart attacks among Vioxx patients. Ultimately, Merck succeeded in obtaining the labeling it sought.
His acknowledgment came during the third week of a trial in which Mike Humeston, a postal worker from Boise, Idaho, claims he suffered a heart attack after taking Vioxx four years ago for knee pain.
The Whitehouse Station-based drugmaker withdrew Vioxx last year after a study uncovered links to heart attacks, although the painkiller had been dogged by such concerns for several years.
For much of the day, Humeston’s lawyer, Chris Seeger, attempted to portray Merck as more concerned with profits than patient safety, using a barrage of Merck e- mails, memos and sales materials to make his case.
Generally, Anstice remained cool, although he appeared frustrated when discussing the company’s motives for haggling for two years with the FDA over an updated warning label for Vioxx.
Seeger displayed a recommendation from an FDA medical reviewer who believed a warning about cardiovascular risks should have been placed in the most prominent spot on the label.
But Anstice insisted Merck disputed that recommendation as it did because the agency misinterpreted data. Merck prevailed when the April 2002 label had a warning in a less prominent position.
The negative publicity about heart risks “was certainly impacting sales,” he said. “And there was a competitive battle (with Pfizer), but we were concerned about getting the right wording” on the label.
The executive turned slightly red in the face when he was confronted with a voice mail he purportedly sent to Merck sales reps in response to a widely publicized article in a medical journal that raised concerns about Vioxx and heart problems.
He testified the September 2001 voice mail contained “inaccurate” and “inappropriate” statements about Merck’s theory explaining Vioxx and heart attacks and strokes.
“I hope I didn’t say that to our sales force,” he said, when shown a written version of the voice mail that was attributed to him and displayed on a screen to the 10-person jury.
Later in the day, Stephen Raber, a Merck attorney, displayed several documents in which Merck responded to FDA requests for information about the labeling issue.
He also cited two FDA approvals for Vioxx issued last year—for migraines in adults and juvenile rheumatoid arthritis. The message was that the FDA continued to say that Vioxx was safe, despite controversy over heart problems.