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By Abe Aamidor
abe.aamidor@indystar.com
December 21, 2004 - Sue Nichols was diagnosed with osteoarthritis six years ago. Not so good, but not so bad, either, as a new wonder drug, Vioxx, proved highly effective in helping Nichols control her pain. Yet she was back to square one this fall when Merck & Co., the manufacturer, pulled Vioxx from the market after it was linked to heart attacks in some patients.

"You don't want to stop taking something that works," said Nichols, a 54-year-old pharmacy technician from Carmel. Like many other patients, however, she was switched to a different drug. The 40 million Americans who suffer from arthritis were dealt another blow Friday: Pfizer Inc., the maker of the arthritis drug Celebrex, said its popular pain-reliever may double the risk of heart attack at high doses. Pfizer did not pull its drug off the market, but the announcement triggered a torrent of new warnings about Cox-2 inhibitors such as Celebrex and Vioxx.

"Physicians should consider this evolving information in evaluating the risks and benefits of Celebrex," said Dr. Lester Crawford, the Food and Drug Administration's acting commissioner. "The FDA advises evaluating an alternative therapy." If a doctor determines the drug is appropriate, it should be prescribed and taken at the "lowest effective dose," he said. Nearly 55 million prescriptions for Cox-2 drugs were written worldwide last year, generating U.S. sales of $5.3 billion. Celebrex was the best-seller among them, with 27 million prescriptions and U.S. sales of $2.6 billion in 2003.

Vioxx, which was introduced in 1999, had 20 million users and worldwide sales of $2.5 billion before it was pulled Sept. 30 after a company-sponsored clinical trial showed increased risk of heart attack and stroke in some patients after 18 months. Now, people like Nichols are seeking replacement therapies -- whether a different drug, a redoubled exercise regimen, an alternative medicine approach or some combination of treatments.

Arthritis usually is divided into two common types -- osteoarthritis and rheumatoid. Osteoarthritis is the chronic degeneration of the cartilage of the joints; it's usually a function of age and wear and tear. Rheumatoid arthritis is a chronic, progressive disease marked by stiffness and inflammation of the joints, loss of mobility and even deformity. Its effects often are seen in the hands and fingers first. Rheumatoid arthritis affects more women than men. Though osteoarthritis is more common, rheumatoid arthritis is considered more crippling overall.

Nichols' rheumatologist, Dr. Douglas Smith, switched her from Vioxx to Mobic -- a drug that is "in between" an older class of medicines known as nonsteroidal anti- inflammatory drugs (NSAIDs include aspirin and ibuprofen) ) and the newer Cox-2 inhibitors such as Vioxx and Celebrex -- and an additional medicine to help protect her stomach. Most people prescribed Cox-2 inhibitors such as Vioxx, Celebrex or Bextra have ulcers or other gastrointestinal problems that prevent them from using the older NSAIDs.

The newer drugs work by stopping Cox-2 enzymes. These enzymes are produced naturally in the body, and blocking them impedes the body's production of chemical messengers called prostaglandins. It is the prostaglandins that are directly associated with the pain and swelling of arthritis.

An alternative to both Cox-2 inhibitors and NSAIDs is Tylenol (acetaminophen).

"If indeed they can get by with Tylenol, then I think that would be a good alternative," said Dr. Matthew French, an interventional cardiologist with the Care Group at St. Vincent Hospital. Physical therapy also is an option to complement drug therapy, and most insurance plans will cover a short series of treatments. Kelly Rickert, a physical therapist at the Rehabilitation Hospital of Indiana, says the goal of therapy is to increase flexibility and strength in the affected joints and surrounding soft tissue.

A specific program has to be prescribed by a physician, she said. Once on a program, it will be up to the patient to continue exercises at home on a daily basis where possible. "Consistency is the key," Rickert said. Water therapy is particularly well-suited to older and/or overweight arthritic patients. "The water gives buoyancy that takes the load off the joints," explained Dr. Jeff Thomas, a staff physician at Clarian Health Partners.

Ninety-year-old Helen Wright has been attending twice-weekly water therapy sessions in the heated pool at the Rehabilitation Hospital for 12 years. She recently went through a sequence of motions with about 10 other patients in the 94-degree water while technician Marvin Acuff gave instructions. "Squats?" Wright challenged Acuff. "What do you want -- my head under water?" It was all good- natured fun; Wright would spend at least an hour in the water in continuous motion. "I have scoliosis and I have arthritis," she later said. "I feel good, even after I leave, for a couple of days."

A popular health-food store remedy that shows some promise is glucosamine chondroitin. Dr. Palmer MacKie, an assistant professor at the Indiana University School of Medicine and a specialist in alternative medicine, says this natural compound offers some pain relief and may retard progression of joint disease. Yet individual trials over the years have been inconclusive, and critics note that there is little or no regulation of such supplements.

In May, the University of Utah School of Medicine launched the first full-fledged, multi-center test of the compound at the behest of the National Institutes of Health; conclusive results may not be available for several years, however.

Weight loss can be a boon to people with arthritis, too.

"The clinical improvement in a patient with osteoarthritis may come with a weight reduction of as little as six or seven pounds," said Dr. Ken Brandt, professor of medicine and orthopaedic surgery at the IU School of Medicine. MacKie says he has tried acupuncture on arthritic patients, but with only mixed results. A recent report in the British Medical Journal says that acupuncture in conjunction with pain medicines provides more relief for osteoarthritis in the knee than pain medicine alone does.

MacKie says he, too, has seen some improvement in osteoarthritic patients who have received acupuncture treatment, but that it hasn't proven very effective in relieving pain in patients with gout, rheumatoid arthritis or lupus. Some patients who cannot tolerate nonsteroidal anti-inflammatory drugs because of ulcers or bleeding think that coated aspirin is an alternative, but that's a myth, says Smith, who is affiliated with St. Vincent Hospital and Rheumatology Associates. "The reason is because the effect of the medicine is not local," he said, meaning that once the aspirin enters the blood stream, it will still act on the gastro-intestinal system whether it was originally coated or not.

Surgery usually is the last option considered because it is so invasive. Nevertheless, it can be very effective. "A lot of patients have done very well with . . . artificial joint replacements," said St. Vincent's French. But it's not a step to be taken lightly. For example, only when the protective cartilage in the knee is worn away and the pain and swelling are too great to function normally would one opt for a complete knee joint replacement. Risks of surgery include infection, blood clots and stiffness or loosening in the joint.

Though Vioxx is off the market, one unanswered question is whether the risk of heart attack reverts to previous levels once use is stopped. Experts say only careful monitoring of former users will tell, but that they believe the risk will indeed subside. In the meantime, Sue Nichols says she has to be content with Mobic, which works, but not as well as Vioxx, she says. "It doesn't last as long throughout the day," Nichols lamented.

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