If Zelnorm Can Return, Why Not Vioxx?
5 CommentsBy Ed Silverman // August 5th, 2007 // 10:21 am
Periodically, the media runs a story about Vioxx patients who lament the 2004 withdrawal of the painkiller, which was yanked over links to heart attacks and strokes. No other med provided relief, they say, before charging such concerns were overlooked by what they perceive as a fickle FDA.
This sort of complaint was a factor in the recent, albeit restricted return of Zelnorm, the Novartis treatment for irritable bowel syndrome. And Merck claims to have received “dozens” of letters from Vioxx fans. So, The Star-Ledger of New Jersey (which, by the way, owns Pharmalot), chats with a few people who hope the same fate awaits the Merck drug.
A Maryland woodworker named Pileggi tells the paper that “I’m not prone to any of the cardiovascular issues. I’m not at risk. To me, it was a godsend.” But other painkillers didn’t help his back pain. “Even with a back support harness on - and I wore one of those all the time - it was like having a knife stuck in your back.” Without Vioxx, he wound up selling his business.
Ben Malcom, 75, retired US Army colonel and racquetball player from Georgia, used Vioxx to relieve arthritic knee pain. “My knees have slowed me down, but when I was taking Vioxx, I could play a good game of racquetball and be competitive…If it came back on the market tomorrow, I would get a prescription and start taking it tomorrow. That’s how strongly I feel about it.”
The Ledger gathered these letters independently. In any event, this is convenient timing for the drugmaker, which is fighting some 27,000 Vioxx lawsuits and sporadic negative publicity, such as the recent release of a study showing Vioxx caused heart problems still faster than Merck originally claimed. For the record, Merck reiterates that the FDA “invited” talks about returning Vioxx, “the company has not made a decision.”
Even though an FDA panel nixed the possibility of Merck’s Arcoxia - better known as Son of Vioxx - from getting approved, the Zelnorm episode suggests the tantalizing possibility that one should ‘Never say never’ about Vioxx. So perhaps we’ll see more such stories until Merck decides a sufficient groundswell of public outcry exists to ask the FDA to convene another panel.
Wouldn’t you like to attend that meeting?
JS
Hey Don’t forget Bextra
Hank
Had Vioxx been marketed in an entirely different way (honestly, once the flags were there), it is not inconceivable that it still would be out there in the form of something reseminbling the Zelnorm regime. That is probably the fate of Avandia as well.
Of course, what we know is that these kinds of “titrating” schemes virtually never work - too many insistent patients, too many docs not paying attention, too much hype.
roccaas
Yes, please bring back Bextra. It remains the best chronic and acute NSAID for me personally. To pull it from the market over Stevens-Johnson Syndrome, while medically sound, was probably a political act on the part of FDA due to the VIOXX issue.
Would someone please do a study looking at S-JS in Naproxen, Ibuprofen, other OTC NSAIDS; I’ll bet they find similar rates of this very rare (but debilitating) condition with drugs that are considered “safe” by the public because you can pick them up even at a Convenience Store.
In the 80’s it was: “I want my MTV”; now that I’m older, “I want my BEXTRA (back)!”
Thanks
tim
Bring back Vioxx I don’t care about potential heart issues. I took it for many years and was living pain free. Now that it is gone I live in chronic pain and had absolutly no problems. At this point I would rather risk a heart condition or death to have more years of no pain. Until you live with chronic pain you have now idea what you would do to be pain free.
Melody
What part of INFORMED CONSENT is so difficult to understand? I was quite happy to see Merck get some come-uppance for their cavalier promotion of Vioxx (as well as Purdue for its oxycontin promotion) . . . I would have been happier if their “punishment” had been even more severe. That said, I nevertheless believe that patients whose quality of life was improved by the drug, and who accept the risks associated with it, should be allowed access to it. When did “the right to safety” become a constitutional guarantee; and who selected “government” as the arbiter? As Mother Jones, RN commented on your “No Experimental Meds” article: THAT’S JUST CRAZY!