Should Vioxx still be on the market?
Until the BP oil spill in the Gulf of Mexico, the recall of Vioxx seemed to be the biggest corporate disaster of the new millennium.
In 2004 Merck pulled the pain reliever, one of a class of drugs called COX-2 inhibitors that had been heralded as miracle cures for chronic pain, from the market after studies showed that it increased the risk of heart attacks. Lawsuits followed. Merck agreed to a $4.9 billion payout, believed to be the largest drug-related settlement in history.
A study in The Lancet estimated that 88,000 patients had heart attacks because of Vioxx and that 38,000 of them died. There have been Congressional inquiries and countless stories digging into the "how did it happen" question, including one of the earliest, How did Vioxx debacle happen?, by Rita Rubin at USA Today. An FDA insider started talking to the press, adding fuel to a fire threatening to seriously damage Merck and the agency.
But time heals all wounds, right?
I listened to two sessions at the Association of Health Care Journalists conference recently in which doubt was cast on what seemed to have become a natural law. Of course, we all thought, Vioxx was a menace to patients everywhere and had to be stripped from pharmacies.
But here was Ivan Oransky, executive editor of Reuters Health and one of the smartest journalists working today, using Vioxx as an example of how reporters often fail to properly explain a drug's risks. "There was a doubling of heart attack risk, but the doubling was from a 1% risk to a 2% risk," Oransky said. "If you lay that all out to readers, they can make much better decisions."
Catherine DeAngelis, the editor in chief of JAMA, went even further. She said:
I believe Vioxx should not have been taken off the market. At least a million people, if told the truth about its side effects, would accept it because their lives could be lived with a lot less pain. There are a lot of people now whose lives are miserable because they have to live with arthritic pain.
Is there a Vioxx revival going on?
I contacted Oransky after the conference and asked him to expand on his comments. He had written a piece for Pharmacy Practice News in February 2006 titled Confused about whether Vioxx caused heart attacks? You're not alone. (You have to register to see it, but the registration is free.)
In it, he wrote:
It perhaps goes without saying that with millions of people taking these medications, any small effect-even on the order of an absolute risk change of 1% to 2%-could mean thousands of additional cardiovascular events. Still, without the actual data, relative risk data-such as "doubling"-don't tell you all that much. I'll leave the withdrawals and approvals to the FDA, and the liability issues to the courts, but I'll let the data speak for themselves.
Oransky repeated this sentiment to me and made the point that, initially, the data behind the Vioxx recall was off limits to reporters because it had not been published. That's what led to some of the vague reporting.
"It wasn't really possible to talk about the absolute risks until 2005, when NEJM published the Bresalier trial with the absolute numbers," Oransky said. "So while reporters should have pushed for it from Merck, it's unclear what would have happened."
He said that reporters need to keep concepts such as relative risk and absolute risk in mind when they are reporting on successful trials (or major corporate failures). I couldn't agree more.
In upcoming posts, I will attempt to explain why those concepts and others matter.