Prescription for Change: Alternative arthritis treatments

By Adriane Fugh-Burman, M.D.

In a surprise move, on April 7th the Food and Drug Administration (FDA) announced that it was withdrawing Bextra (rofecoxib) from the market. Bextra is a COX-2 inhibitor, a class of drugs that blocks the COX-2 enzyme and thereby reduces pain and swelling, such as that caused by arthritis. The FDA is also requiring the COX-2 inhibitors still on the market to carry a “black box” warning (the FDA’s most severe type of warning) stating that the drugs may increase the risk of heart attacks and other health problems.

This is really good news: science won over commercial interests this time. The FDA’s move clearly indicates that it believes the risks previously identified with Vioxx (the COX-2 drug withdrawn from the market in September, 2004) are a “class effect”— meaning that increased risks are not limited to Vioxx but extend to the entire class of COX-2 inhibitors.

What is stunning about the FDA’s decision is that it went against the vote of its Advisory Committee, which had decided in February to allow the continued marketing of COX-2 inhibitors, including Celebrex (celecoxib) and Bextra. The Committee even voted to allow Vioxx (valdecoxib) to return to market.

The FDA usually (but not always) follows its Advisory Committees’ recommendations. And rebellion against the Committees is not always science-based; the FDA prevented Emergency Contraception (EC) from being made available over-the-counter even after an Advisory Committee voted overwhelmingly that EC is safe and effective and should be more widely available.

So, chalk one up for the good guys. The vote is even more surprising because the Committee was heavily stacked in favor of industry. According to an analysis commissioned by The New York Times, and conducted by the Center for Science in the Public Interest, 10 out of the 32 Committee experts have consulted for COX-2 manufacturers in recent years. Nine out of these ten experts with clearly relevant conflicts of interest voted to keep Bextra on the market and allow Vioxx to return to the market. Had their votes been excluded, the Committee’s recommendation would have been to keep Vioxx off the market and to withdraw Bextra.

One scientist, Curt Furberg, had his invitation to serve on the Advisory Committee revoked last year after he publicly stated that the cardiovascular risk of COX-2 inhibitors is a class effect. Furberg was labeled “intellectually biased”, a ridiculous—and dangerous—charge that apparently meant he had an unpopular opinion. Despite the fact that COX-2 inhibitors are no more effective for pain than good old, generic nonprescription painkillers such as aspirin, ibuprofen, and naproxen, they have been successfully over-promoted to both physicians and consumers. The primary advantage of COX-2s was supposed to be that they were easier on the stomach than other painkillers, but even that claim turned out to be exaggerated. And, the increased risk of heart attacks and other serious problems certainly diminishes any gastrointestinal advantage COX-2 drugs might have.

Many people take daily painkillers because they have arthritis. Given that no painkiller is without risks, why has public discussion of the COX-2 debacle focused only on drugs and not on alternatives that people can use instead? Here are some suggestions.

Adverse effects of drugs are usually dose-related, so it is important to take as little medication as possible. One way to do this is to switch to topical medication, which is applied to the skin rather than swallowed. Topical preparations are more efficient, because they are applied close to where it hurts. Moreover, they cause very few stomach problems because they don’t go through the stomach; only low levels of topical preparations enter the bloodstream, so all side effects are much lower.

Many doctors do not know about the availability of topical painkillers, so don’t be surprised if such a request elicits puzzled looks. Diclofenac, a topical prescription analgesic, is one topical drug that’s available in the U.S. Ask your doctor to prescribe topical diclofenac sodium 3%, 100 grams, ½-1 cc to be applied three times a day. A compounding pharmacy (an old-fashioned pharmacy that makes pills, syrups, and creams) can also make up a topical gel from ibuprofen or ketoprofen, a relative of ibuprofen. A prescription can be written for topical ketoprofen gel 20%, 40 mL; ½-1 cc to be applied three times daily. Ibuprofen gel can also be made up by a compounding pharmacy, and commercial versions are popular in the U.K. My favorite pharmacist tells me that the compounded ketoprofen gel is better absorbed than ibuprofen, however. Capsaicin cream is an herbally derived, nonprescription, topical pain medication made from chili peppers that works by blocking pain sensations. Many brands are available at drugstores. Be careful not to rub your eyes after applying it, though!

Several dietary supplements have also been shown to be effective for arthritis pain. Glucosamine and chondroitin are both natural products sold as dietary supplements in many stores; clinical trials support their use and both are harmless. The usual dose of glucosamine is 500 mg, taken three times daily; for chondroitin, the typical does is 400 mg, three times daily. Chondroitin may have a larger effect, but it is much more expensive than glucosamine, and combination products often contain little chondroitin.

SAMe (pronounced “Sammy”) is short for S-adenosylmethionine, an amino acid derivative that is effective for arthritis, although it is quite expensive. It is prescribed as a conventional drug in Europe, where the usual dose is 1600 mg per day.

Finally, exercise is important in easing osteoarthritis symptoms; one small study showed a benefit of yoga exercises for arthritis of the hands. Acupuncture has been shown to be more helpful over a placebo for osteoarthritis of the knee.

It makes sense to try some gentler, non-drug therapies to see if they can decrease (or rarely, eliminate) the need for drugs. Reducing the use of painkillers can help prevent some of the serious problems associated with these drugs.