Arthritis Drugs Risk-Benefit Equation. Recent reports on the dangers of drugs used to treat rheumatoid arthritis have left patients and their doctors grappling with a complex risk-benefit equation.
The most painful and crippling form of arthritis shortens lives and renders most of its victims unable to work within 10 years.
At the same time, these drugs leave patients vulnerable to life-threatening infections, cancer and organ failure.
But for Rebecca Boren and others who face daily pain and disability, those are risks worth taking – even when the ultimate risk is death.
“As my doctor said, would you rather have five quality years or 15 crappy years?” says Boren, 45, a former Seattle Post-Intelligencer reporter whose arthritis forced her to quit her job and move to Tucson four years ago.
Tucson rheumatologist Dr. Karen Smith says all risk is relative.
“Medicine has risks. Life has risks,” Smith says. “The disease that we treat with these medicines is very serious and very disabling and has a really negative impact on people’s lives.”
Rheumatoid arthritis affects 2 million Americans. About one in 25 people in Southern Arizona has rheumatoid arthritis – twice the national incidence, because so many people who suffer from the disease move here for the climate.
It is a complex immunological disorder in which a patient’s own immune system attacks his or her joint cartilage, the cushiony material that keeps joints moving smoothly.
Recent reports brought to light dangerous risks with three of the most promising new treatments for the disease.
For more information on arthritis, including alternatives to traditional medicine, visit StarNet’s Health site.
Vioxx increases risk of heart attack
A “biological response modifier” called Remicade can trigger tuberculosis and other infections, and death. An anti-inflammatory drug called Vioxx increases risk of heart attack.
And the drug Arava has caused liver failure and death in 12 Americans, according to the Public Citizen Health Research Group, which two weeks ago petitioned the Food and Drug Administration (news – web sites) to take Arava off the market.
Boren knows all about those risks, and others.
In the seven years since she was diagnosed with rheumatoid arthritis, she has tried nearly every drug available. An immune-system suppressant called Imuran so depleted her white blood cell count that she was in bed for a month with a severe respiratory infection.
A cancer drug called Cytoxan kept her disease in check, in exchange for severe weight loss, hair loss and nausea.
Three years ago, on Remicade, she developed the second known case of another autoimmune disease, lupus, linked to the drug.
Now she’s on Vioxx, Tylenol with codeine and methotrexate, a cancer drug that attacks the white blood cells responsible for rheumatoid arthritis but, like Arava, carries a significant risk of liver failure.
She is waiting to get on another new drug through a clinical trial at the University of Arizona Arthritis Center.
“A lot of people shy away from some of the things I’ve taken. But I’m a lot more at peace knowing I’ve tried everything than I would be if I thought somewhere there was a drug that could do wonders for me, if only I tried it,” she says.
Diane Kounovsky, 53, of Tucson has suffered from rheumatoid arthritis for 36 years. The disease has so ravaged her joints that she has undergone 15 operations to repair or replace her fingers, thumbs, elbows, hips, knees and ankles.
Like Boren, she has run the treatment gamut. Currently she takes methotrexate and two of the more potent drugs developed in recent years: Enbrel, a drug in the same class as Remicade, which carries similar risks of infection, and Celebrex, a drug similar to Vioxx that may pose the same heart risks.
“I feel like I have to weigh the risk with what this disease would do to me if I didn’t have the drug,” Kounovsky says. “When you read everything, it scares you. And yes, people could get into some really dire situations with these drugs. But you’re monitored closely, so if you develop problems it’s going to get caught pretty fast.”
With Arava, that may not be the case. The drug has been linked to acute liver failure – a sudden and fatal change that can be detected by a blood test, but not necessarily in time. For that reason, Public Citizen wants the drug banned.
But Socorro Sanchez of Tucson considers Arava a miracle drug, and she has no intention of stopping it.
Before Arava, Sanchez was so crippled with rheumatoid arthritis that she could no longer cook or clean house, work in her garden or enjoy her great-grandchildren.
“Now I’m able to do everything,” says Sanchez, 83, who has taken Arava for two years.
After 15 years on other medications, Sanchez was spending her days in a wheelchair. Then she began Arava, and she gradually improved enough to get by with a walker, then a cane. Now she gets out of bed every day at 5 a.m. to garden and do the other things she enjoys.
“I do understand the risks, but I think there are risks in a lot of drugs nowadays,” Sanchez says.
Susan Brooks, a spokeswoman for Aventis Pharma, which makes Arava, said Monday that the company is still reviewing the Public Citizen petition.
“We do plan to issue a formal response,” said Brooks. “Aventis and the FDA are aware of the reported adverse events in patients taking Arava, and based on our review of those reports, we have been in discussion with the FDA regarding labeling since before the petition was filed. . . . Aventis continues to believe that Arava is safe and effective when used as directed.”
Dr. David Yocum, director of the UA Arthritis Center, helped develop many of the rheumatoid arthritis drugs in use today. He previously served on the FDA’s arthritis drugs advisory committee and was its chairman for two years until last fall.
“The issue is one of informed consent,” Yocum says. “All we ask for, and all our patients ask for, is the information we need to make appropriate choices.”
Yocum says the risks associated with Arava, Remicade, Vioxx and other drugs are based on reports of adverse effects experienced by less than one-tenth of 1 percent of the people who take the drugs.
Yocum ran clinical trials of Arava and therefore recused himself when the FDA advisory committee voted to approve the drug about four years ago. But two weeks ago, he wrote a letter in support of Public Citizen’s effort to ban the drug.
“None of these are benign drugs,” Yocum says, referring not just to Arava but to Remicade, Enbrel, methotrexate and others. “The key issue is the balance of efficacy and toxicity. And my concern with Arava is the inability to predict who might die, and I think that’s scary.”
Remicade has been linked not only to tuberculosis but, in Phoenix and Las Vegas, three people on the drug have died from valley fever, Yocum says.
That’s a different kind of risk, he says. Blood tests and chest X-rays can catch those infections, and they can be treated. Patients on Arava are to get frequent blood tests to check liver enzymes that, when elevated, signal potential liver failure.
But the liver failure linked to Arava can be so sudden and severe that nothing can be done to save the patient, Yocum says.
Further, Yocum wrote in his letter supporting the Public Citizen petition, two UA Arthritis Center patients died while on Arava – one from liver failure, the other from high blood pressure and stroke.
Dr. Linda Karl, a Tucson rheumatologist, says Arava is an appropriate choice for some patients, but side effects have led her to discontinue Arava in patients more often than any of the other new drugs.
“I would say I’m extremely pleased with the results in about 50 percent of the patients I’ve put on Arava,” Karl says. “In 10 to 20 percent, I don’t think it’s been effective at all. And I’ve had a few scary liver enzyme elevations. . . . We stopped the drug immediately, and the patients did well.”
The FDA has not commented on the petition to ban Arava, except to say it will review it. “Patients have to be aware that drugs do have risks and benefits,” says FDA spokeswoman Susan Cruzan. “When we have information like this (the Public Citizen petition), we thoroughly evaluate it and determine what course of action to take.”
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