Healthy Skepticism Library item: 9414

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Publication type: news

Hensley S.
Pharma Box Office: Where Did Vioxx Users Go?
The Wall Street Journal Health Blog 2007 Apr 12
http://blogs.wsj.com/health/2007/04/12/pharma-box-office-where-did-vioxx-users-go/

Notes:

Charts not reproduced here.

Full text:

Merck takes a tenatative step toward FDA approval of painkiller Arcoxia, son of Vioxx, today before a panel of experts advising the agency. So the Health Blog wondered: What did the people taking Vioxx do after it was pulled from the market in 2004?

The most surprising answer is that two years later, some 33% of Vioxx users weren’t filling prescriptions for any analgesic medicines at all, according to an analysis of health claims for Health Blog performed by Thomson Healthcare.

The folks at Thomson combed their database of claims to find patients who had been taking Vioxx regularly (at least a 90-day supply) in 2004. They identified 104,000 Vioxx patients, average age 62.6 as of Sept. of that year, who were continuosly insured and in the database through the third quarter of 2006. (The claims database draws information from employer-based insurance plans and has stats on more than 20 million people.)

Thomson looked at what the ex-Vioxx users did after the drug was pulled over cardiovascular risks. Of those still taking prescription pain meds during the first three quarters of 2006, the most popular choice was opiates, such as Vicodin, taken by 39% of patients who had been on Vioxx before it was withdrawn. But that figure isn’t quite as startling as it might seem at first blush. Among the Vioxx users in 2004, opiates were also popular, taken by about the same percentage of them during the first three quarters of the year.

Often prescribed for chronic arthritis pain, Vioxx was used by about 20 million people in its five years on the market. The so-called Cox-2 inhibitor was supposed to relieve pain while carrying lower risk of gastrointestinal problems, such as bleeding ulcers, than older medicines such as naproxen and ibuprofen.

“Pain management remains a big issue, and the Vioxx removal has left both patients and physicians with limited choices,” says Bill Marder, head of research at Thomson Healthcare. “For some of these people it seems to be an unsatisfying choice because theyr’e dropping out of this market.” That’s what Merck is banking on as it presents data on Arcoxia to the FDA panel.

A look back shows that immediately after Vioxx was withdrawn, patients flocked to other Cox-2s, namely Celebrex and Bextra from Pfizer. In the fourth quarter of 2004, some 39% of the Vioxx users had moved on to those drugs. But as safety concerns rose for the entire Cox-2 class, including the withdrawal of Bextra by Pfizer in April 2005, the use of Cox-2s dropped to 26% during the first three quarters of 2005 and to only 16% during the comparable period in 2006.

Other prescription nonsteroidal anti-inflammatory drugs, a category that includes ibuprofen and naproxen, was the biggest gainer over the long haul. Some 36% of the former Vioxx users were taking NSAIDs during the first three quarters of 2006 compared with only 11% taking them in addition to Vioxx during the first three quarters of 2004. The single-biggest NSAID winner was meloxicam, or Mobic, used by 12% of patients during the first three quarters of 2006 compared with only 2% of Vioxx users during the same period in 2004. Mobic is sold by Boehringer Ingelheim.

One important limitation of the Thomson database is that it doesn’t capture information about over-the-counter meds. Still, it’s clear that Celebrex didn’t make a clean sweep of ex-Vioxx patients, as some people expected.

Michael Parks, an orthopedic surgeon at Mount Sinai School of Medicine in New York, tells the Health Blog that some of his patients “switched over to Celebrex, but many were leery of being on the Cox-2 inhibitors” at all after the safety warnings. “There are some people who said they would live with the pain,” he says, resorting to over-the-counter medicines when their arthritis flared up. And still other patients, who had tolerated their aching joints, finally decided to replace them with artificial hips and knees.

Steven Abramson, a rheumatologist at NYU School of Medicine, tells the Health Blog that “some people got off Vioxx and tried other NSAIDs.” But the NSAIDs, including over-the-counter medicines, weren’t adequate for many,” says Abramson, who has consulted for both Merck and Pfizer. “My instinct is that between the peak use [of Cox-2s], which was probably overuse, and the current use there’s a group of people who are being undertreated.”