It's Official: No FDA approval for Arcoxia

As suspected, the FDA declined to approve the COX-2 drug etoricoxib (Arcoxia) – Merck's follow-up to the COX-2 Vioxx, which they pulled from the market in 2004. Arcoxia data was reviewed by the FDA's Arthritis Advisory Committee several weeks ago, but the committee voted 20 to 1 against recommending its approval. Although the FDA does not have to follow the recommendations of the advisory committee, it usually does.

Although the official "nay" to approval is not surprising, it leaves the one remaining COX-2 on the market – Celebrex – as the only option in that class of nonsteroidal anti-inflammatory drugs (NSAIDs). Some people with arthritis found the two defunct COX-2 drugs, Vioxx and Bextra, to work better for them than Celebrex, and were looking forward to a potential new option that might provide pain relief while sparing the gastrointestinal irritation and side effects of traditional NSAIDs. Others, both patients and doctors, have been concerned about the safety of not only the COX-2s, but all NSAIDs, since more has been learned about the risks in the past three years.

Is it better to have a pain relief option that may increase your risk of a cardiovascular side effect, if being more functional will help you be active enough to reduce your cardiovascular risks through exercise? And if you could exercise more, would you? Or would you rather not take the risk of affecting your heart? Why or why not?

I'm working on an article right now about this entire issue, which includes comments from you, readers who answered Arthritis Today's latest online poll, as well as doctors on both sides of the issue. Look for the finished version in the July-August issue. In the meantime, it's not too late to voice your opinion on the subject. Leave a comment to this post and share your thoughts. If you're OK with me including your comment in the published version of the article, just say so. (Be sure to include your name, city/State, age and arthritis condition; don't worry, I'll delete all that information before I post your comment.)

Donna Siegfried

Beyond the Headlines, Again

Yesterday the Arthritis Today editors attended the annual conference of the Magazine Association of the Southeast (MAGS). After we spent a full day learning mostly about how to make our Web site better and more interactive, we spent a nice evening at the awards banquet and were thrilled to have received several awards. The Supplement Guide we published in the Sept-Oct 2006 issue won the gold award for Best Design, the magazine overall won a bronze award for General Excellence and we won a gold award in the Best Service Journalism category for an article that appeared in our July-August 2006 issue, called "Beyond the Headlines."

If you subscribe to the magazine, you might remember it. The article opened with a skeptical-looking man reading a newspaper (note the made-up headlines and article!) and addressed the flip-flops that broke in the news at that time. Incidentally, "that time," was two weeks before we went to production. This was an article that we felt we had to do and we had to do immediately. It absolutely had to go into the next issue, even if it meant long nights pulling together and analyzing the research on studies that were released then – ones that said calcium and vitamin D weren't as beneficial for bones as previously thought, that low-fat diets don't reduce risks of cancer or heart disease, and that glucosamine/chondroitin aren't really effective. We highlighted what most news reports said, gave you insight into reactions that followed the news and then told you the whole story, pointing out what other media failed to mention. Our contributing editor Denise Mann did a great job writing to our vision, and AT's editor-in-chief, Marcy O'Koon, gave me great input on my edited version to make it work even better. We really won the Gold Award last night for a great group effort.

It's ironic that this article won an award last night, considering that chondroitin is back in the news. Reports now say that chondroitin – on its own, anyway, and in three out of 22 studies – just isn't effective. However, consumers are buying more of it and saying it works for them. The bottom line is that the supplement isn't harmful, so most doctors are neither recommending its use or discontinuation. But here we are addressing this issue once again, as we'll continue to do. After all, once an article is published, that's not the end of it for us here. There is indeed far more beyond the headlines. Keep reading.

Tomorrow's a Big Day

Shhh. Hear that buzzing sound? It's people discussing what may happen tomorrow at the FDA's Arthritis Advisory Committee meeting. There, experts will be debating whether another COX-2 drug, etoricoxib (Arcoxia), will likely be recommended for approval. Arcoxia is a successor to the now-defunct Vioxx in that it's another COX-2 manufactured by Merck. Safety of patients versus the need for treatment options for patients likely will be the hot topic. I'll be watching and listening as the news unfolds, but I'm curious in what you think the outcome will be. No water-cooler bets have been placed around here, as far as I know, but go ahead and take a guess. Let me know if you think the FDA committee will recommend it be approved or sends it back to the drawing board -- why or why not? And be sure to let me know what you wish/hope will happen tomorrow and in the future.

Donna

Dolphin Therapy

I just returned from a great Spring Break week on Hilton Head Island, in South Carolina. The weather was gorgeous for most of the week – 80-degree sunny days until the cold snap Friday night, and only one quick thunderstorm. Although it's always wonderful to simply hang out with my family, play in the sand with my kids, go for bike rides and take life more slowly, work is never completely out of my mind. I can't help it. My work compels me to always have my antenna up for the latest news, promising research or personal story.

While I'm walking on the beach, I'm observing some of you struggling with a bad knee as you cross the shifting, dry sand or perservering through pain while you make sure you get in that walk on the beach. Last week I was quite impressed by an 80-some-year-old man who was obviously severely affected with osteoporosis out on the beach every day for a walk. He could barely look up to see where he was walking, yet he walked. Sure, he walked slowly. But he walked. He kept at it. He didn't say, "I can't; it hurts." He must have said, "I'm going to keep walking so I can CONTINUE walking." Knowing what people who have osteoporosis go through, I was so proud of him.

As I relaxed in my beach chair or sat with my family at a great seafood restaurant, I overheard some of you talking about hip replacements, supplements, medications or the benefits of the omega-3s in your salmon. Sometimes – usually when I'm not with my entire family – I join in the conversations. Once in a while I'll explain why I'm so interested. I'll 'fess up to being the medical editor of Arthritis Today, or I'll simply say I'm a patient, too, while hoping that you'll tell me you got your information from our magazine. But mostly I just listen – and think. I think of article ideas, and I think of what it must be like to be in your shoes, rather than my sandals. I think about questions for researchers and doctors, and I think about what answers they might give you – and what else you may still wonder.

During the night of the quick thunderstorm, my family and I watched a television show about dolphins. I have always loved dolphins, which is one reason we enjoy Hilton Head so much. There hasn't been one visit to Hilton Head in which I haven't seen dolphins. If I could be an animal, I'd choose to be a dolphin – they're intelligent, they get to swim and play all day, they're great communicators and they're loved. According to the show I watched, they may help people with chronic conditions, too. Although I've been a fan of dolphins all my life, I had never heard of dolphin therapy. Rest assured I'll be checking into it, though. Apparently swimming with dolphins provides relief to those in chronic pain or depression. The experts theorized the sounds emitted by the dolphins could increase the production of endorphins in humans. Or maybe swimming with dolphins is so utterly peaceful, you can't help but feel better when you're around them.

The morning after that program aired, I was watching my husband out in the ocean with my kids when all of a sudden a dolphin dove not 30 feet in front of them. I immediately headed for the water, hoping I'd get there quickly enough to have the chance of seeing one up close. The kids were encouraging it to come back and hoping it would come close enough so they could touch it – and they weren't the only ones. It seemed that everyone on the beach was drawn to the water when that dolphin came so close to shore. People headed toward the water in droves, pointing and smiling – including the 80-some-year-old man with osteoporosis who was out for his walk. I doubt pain relief was on anyone's mind at that moment, but I have no doubt we all felt happy, peaceful and better. Free dolphin therapy for all.

Everyone on the beach that morning was enjoying the beautiful dolphins, and I was enjoying watching everyone do so – and thinking about what you Arthritis Today readers would be wondering. Watch the pages of the magazine to see what I find.