The events that led to Merck’s decision to pull Vioxx off the market has raised deep questions about what the company knew and when, and about whether the FDA is living up to its role in protecting public safety.
The news of Sept. 30 was stunning. “Merck is announcing a voluntary, worldwide withdrawal of Vioxx,” Raymond Gilmartin, the company’s chief executive, said then.
It was the biggest prescription drug recall in history. A blockbuster suddenly pulled from the market due to risks of heart attack and stroke. The popular pain reliever, relied upon by an estimated 20 million people, was thought to be a wonder drug.
But the recall announcement, sadly, wasn’t surprising to Evelyn Plunkett. She believes Vioxx killed her husband.
“I saw it on TV that morning, and it was like, ‘thank God,'” Plunkett says.
The death of Plunkett’s husband Dickie Irvin is just one of the many tragic stories behind the headlines about the Vioxx recall.
It made me mad,” she says. “It made me really angry that it took so long.”
Lisa Gregg blames Vioxx for what happened to her husband Jamie, who lies in a hospital bed in Texas after suffering a massive heart attack. “He can’t walk,” she says. “He can’t feed himself. He barely vocalizes. He’s just not the same.”
Plunkett and Gregg are asking what may be the most important question about Vioxx: Did they and their loved ones suffer, or die, needlessly?
By almost any measure, the Vioxx recall is likely to have far-reaching implications for business, health care and the legal community.
A radical decision
Merck’s decision to pull Vioxx was radical, and for good reason. A study Merck was conducting on the use of Vioxx in preventing colon polyps found something alarming: Vioxx users taking the drug for more than 18 months were twice as likely to have heart attacks or strokes.
What followed was a mad scramble. Pharmacy shelves were immediately cleared of Vioxx, ads were bought and doctors sent announcements to their patients. The reaction on Wall Street was swift as well Merck’s stock dropped 40%.
And almost as quickly came questions about Merck. Had the company marketed Vioxx ignoring previous red flags about the popular drug? What did Merck know, and when did it know it?
By November, Washington was involved. The Senate Finance Committee launched an investigation into Vioxx. On the hot seat was CEO Gilmartin.
“Well, given all the safety data that we had our marketing was appropriate,” he told the committee.
The hearing was contentious, with some of the committee’s greatest scorn reserved for the Food and Drug Administration, which oversees drug approval and safety.
But the real star that day was an FDA scientist, Dr. David Graham. “Vioxx is a terrible tragedy and a profound regulatory failure,” he said.
Graham, a top FDA researcher in drug safety, stunned the room by speaking out against a culture at his employer that he says allows dangerous drugs to stay on the market.
A worrisome symptom
“What happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people,” he says.
He adds, “What I think these people may be trying to do is to disown the fact that 100,000 people had a heart attack due to Vioxx because of FDA’s actions.”
Merck is fighting back in the court of public opinion, but the company’s most difficult battles may be ahead. It faces hundreds of personal injury lawsuits that have already been filed. Merck will be in court facing people like Plunkett.