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Unbottling the Pain ; Patients Are Wondering Where to Go for Relief

Posted on: Saturday, 12 February 2005, 03:00 CST

The drumbeat against prescription painkillers has been pretty steady for the last few months.

One drug off the market. New warnings for another. Studies scrapped over heart worries.

It has created a quandary for doctors and patients as they sift through the headlines and sometimes conflicting studies.

"We don't know what's safe anymore," says Dr. Martha D'Ambrosio, with Arthritis Associates & Osteoporosis Center of Colorado Springs.

The only winner in the whole mess may be the already booming alternative-medicine movement, as more people embrace drug-free therapies. But doctors warn against jumping on that bandwagon too hastily.

The tide of bad news began in September, when Merck & Co. pulled Vioxx off the market after a long-term study found an increased risk of heart attack and stroke. In December, similar worries caused the National Cancer Institute to halt the use of Celebrex in a colorectal cancer trial. The Food and Drug Administration, meanwhile, approved new warnings for Bextra concerning life- threatening skin reactions and cardiovascular risks.

Last week, two more studies pointed to the potential dangers of the entire class of drugs known as Cox-2 inhibitors.

Vioxx, Celebrex and Bextra, all popular, prescription-only arthritis drugs, make up the Cox-2s. They're a new generation of nonsteroidal antiflammatory drugs, or NSAIDs, which reduce pain and inflammation. The Cox-2 inhibitors were designed to prevent the gastrointestinal bleeding associated with the older NSAIDs, which include naproxen, aspirin and ibuprofen.

"What's happening is we're going to end up going with the more traditional ones and we'll see a big increase probably in stomach bleeding, and deaths and admissions from that," D'Ambrosio says.

But the bad news hasn't been confined to the Cox-2s. In December, it was reported that a clinical trial had pointed to an increased risk of cardiac problems in long-time users of naproxen, sold over the counter as Aleve.

FDA URGES RESTRAINT

The news on the Cox-2 inhibitors wasn't a great surprise to many doctors. Earlier studies also had associated Vioxx with cardiac problems.

The news on naproxen, though, was surprising, says Dr. Lawrence Zyskowski, a rheumatologist with Colorado Springs Health Partners. He points to its long history -- the prescription version has been available for nearly 30 years -- and to a study that found Aleve "cardiac protective" compared with Vioxx.

"With the Aleve, I think the data's not very secure at this point in time. It's very confusing," Zyskowski said.

An FDA public meeting in mid-February will address that confusion. For now, the FDA urges consumers to strictly follow label directions on over-the-counter pain medicines and not use over-the- counter NSAIDs for more than 10 days without consulting a doctor.

The FDA also instructed physicians to carefully weigh risks and benefits when prescribing Celebrex and Bextra, which are still on the market.

Some of Zyskowski's patients remain on low doses of those drugs. Others have switched to the older class of NSAIDs, either because of safety concerns or because their insurance companies have dropped the Cox-2 inhibitors from their coverage.

"Some of them have found the switches to be OK," Zyskowski says. "Some of them have found them to be not as effective or to have more side effects."

One of his patients, Yolande Amundson, had to drop Vioxx once it was pulled off the market. She tried Bextra but found it wasn't as effective. She now takes ibuprofen, which she says helps about as much as Bextra and at a fraction of the cost.

Amundson, 52, has psoriatic arthritis, which combines the scaly rash of psoriasis and the pain and inflammation of arthritis. She wishes Vioxx, which did the best job by far in relieving her pain, was still available.

"I think they should have handled this by relabeling or doing a better job of labeling, because it's not clear that the risks outweigh the benefits."

She doesn't have much faith in alternative treatments such as acupuncture, which a recent study found offered significant pain relief for people with arthritis of the knee.

"I'm not inclined that way," Amundson says.

Jim Tannehill takes Aleve when his osteoarthritis flares up. He tried Celebrex for a few weeks, but didn't find it more effective than the cheaper, over-the-counter medicine.

Tannehill, 65, is a patient of Dr. Joel Klein, who combines traditional and alternative therapies in his practice, the Klein Center for Holistic Medicine. Tannehill takes supplements to treat his arthritis, including glucosamine, which is believed to improve joint mobility and slow the deterioration of cartilage, and fish oil, which fights inflammation.

Tannehill also restricts his diet, avoiding refined sugars and members of the nightshade family, such as eggplant and peppers, which may promote inflammation.

Pain medicines have their place, he says, and he has no qualms about taking an occasional Aleve. But he feels many people reach too quickly for a pill.

"You're smothering the pain but you haven't done anything to address the cause of the pain," he says.

DOCTOR GOES FOR BALANCE

Klein says NSAIDs are overused, particularly for relatively minor ailments such as tendinitis or bursitis.

Arthritis doctors commonly see the most severe cases of arthritis, "so their patients probably need this stuff," he says.

But even those patients might benefit from nontraditional treatments that could reduce their need for the medicines, Klein says.

D'Ambrosio is wary of alternative therapies, citing a general lack of data supporting their effectiveness. The Institute of Medicine noted that lack in a report this month that called for stricter regulation of dietary supplements. The report urged Congress to act to improve quality control and consumer protections and to encourage research on the products' efficacy.

Klein acknowledges the lack of regulation and agrees a label of "natural" doesn't ensure safety. "But most of the stuff out there is fairly benign."

People in the natural-health community can be as one-sided or biased as the most conservative doctor, blasting all drugs, Klein says. He strives for a balance.

"I don't come in and tell people, you have to stop this stuff right now. Look, you stay on the medicines, then we'll use this other stuff over time and your body or your lab work will say whether we can start peeling it away."

CONTACT THE WRITER: 636-0272 or comics@gazette.com

WHAT'S AN NSAID?

Nonsteroidal anti-inflammatory drugs, or NSAIDs, work by inhibiting enzymes responsible for the body's production of prostaglandins, hormone-like substances involved in inflammation and pain. But traditional NSAIDs also decrease production of a prostaglandin that protects your stomach lining. This allows gastric acid to erode the lining and cause bleeding and ulcers. The newer NSAIDs, called Cox-2 inhibitors, were designed to reduce gastrointestinal problems by blocking only the enzymes associated with the prostaglandins contributing to pain and inflammation.

SOURCE: www.mayoclinic.com

GETTING HELP

The Arthritis Foundation offers comprehensive information on alternative arthritis therapies at www.arthritis.org/conditions/ alttherapies. Southern Colorado branch of the Arthritis Foundation: 520-5711.

The Food and Drug Administration's public-health advisory on nonsteroidal antiflammatory drugs can be read online at www.fda.gov/ cder/drug/advisory/nsaids.htm.

Public Citizen, a Washington, D.C.-based nonprofit public- interest group, offers cautions against numerous drugs at www.worstpills.org.

"Relieving Pain Naturally" by Sylvia Goldfarb and Roberta Waddell, published recently by SquareOne Publishers, provides a guide to drug-free pain management for conditions ranging from arthritis to migraines to tennis elbow. $18.95.

The National Center for Complementary and Alternative Medicine, part of the National Institutes of Health, offers information on supplements and other therapies at www. nccam.nih.gov.

Source: Gazette, The; Colorado Springs, Colo.

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