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Patients Urge FDA Panel Not to Ban Painkillers

Hearing gets personal tales of pain relief with cox-2s

THURSDAY, Feb. 17, 2005 (HealthDay News) -- Dimitra Poulos has known pain so crippling that she once was unable to rise from the toilet.

"My husband found me crying," she recalled.

In fact, her husband had to assume many tasks, including that of dressing Poulos, after she was diagnosed with rheumatoid arthritis in 1998. At one point, her condition had deteriorated so badly that she couldn't sit in a movie theater, go for walks or take car trips to see members of her family.

Vioxx, however, changed her life.

"It gave me my life back. I've had no side effects. Known risks can be dealt with," she said.

Poulos recounted her story during the second of three days of hearings held by two U.S. Food and Drug Administration (FDA) advisory committees on the safety of Vioxx and other cox-2 painkillers. Vioxx was pulled from the market last September after studies revealed that longtime users were at heightened risk of heart attack and stroke. Similar concerns surround the whole family of medications.

"I have 40 pills left, 40 days before my life and ability are severely altered," Poulos stated. "I will assume all liability and sign any waiver. Please give me that option."

Poulos was one of a dozen or so people who took to the podium in Washington, D.C., Thursday afternoon, almost all of them arguing to keep cox-2 inhibitors, including Celebrex and Bextra, on the market. In all, about 50 members of the public, including physicians and consumer advocates, used the few minutes allotted to them to speak their mind.

Amye Leong, a motivational speaker, described the rheumatoid arthritis that took over her life as a teenager, 25 years ago. "Within eight years of diagnosis, I ended up in a wheelchair unable to feed myself," she said, standing before a microphone.

Leong recounted that she has undergone 16 surgeries and taken more than 135 different arthritis medications, including "every single NSAID and celecoxib." In balancing the risks and benefits, she asked members of the committee to consider her "a standing benefit."

"It is my choice to work with my physician to determine what is a higher risk for me," she said.

The theme of personal choice and personal responsibility was a common one during the testimony.

Betsy Chaney has cracked vertebrae in her neck and, without Celebrex, starts to lose feeling in her hand, she said. "I'm concerned that you all will take away my ability to make a decision with my physician, my family and my friends," she told the committee. "Please don't take this medication that works so well for me. What matters is that I retain the right to make a decision with my doctor and my family to continue to take this medication even if there are risks. I'm willing for my quality of life to take those risks."

Professionals also echoed the refrain. "We believe patients should be able to choose for themselves whether the benefits outweigh the risks," said Dr. John Klippel, president of the Arthritis Foundation.

Testimony occasionally came from surprising corners. Maj. Christopher Grubb, M.D., a pain specialist with the Department of Defense, stated that cox-2 inhibitors are "essential to the global war on terrorism" and that military personnel who suffered injuries need the drugs.

"Soldiers take [cox-2 inhibitors] into battle," he said. "We urge against using a broad brush when painting a portrait of risk."

There were fewer personal voices on the other side of the debate.

Eileen Lacijan, a 57-year-old nurse and executive director of a hospice program in Arnold, Md., was one. First prescribed Vioxx in 2000 to combat pain from arthritis in her hands, she later switched to Celebrex and then, four years later, to Bextra. On the evening of Aug. 12, 2004, she survived a heart attack that initially resulted in a "moderately large amount of heart damage."

"I have never smoked, don't drink alcohol, don't have diabetes or any family history of heart disease, don't have high blood pressure, I exercise and I'm not overweight," she said. "I still have many unanswered questions about the cause of my heart attack."

While Lacijan stopped short of pinning her heart attack directly on the drugs she had been taking, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, was less reticent. In a statement, he called for an outright ban of Celebrex and Bextra, "given that [they] are making an important contribution to the estimated 100,000 deaths and 2.1 million serious injuries a year from adverse drug reactions."

"Label limitations to short-term use will fail, just as they did with the now-banned NSAID, Duract," he added.

The three-day hearings end Friday. That will be the earliest possible time the committee's final recommendations are made public.

More information

For more on cox-2 drugs, visit the FDA.

SOURCES: Feb. 17, 2005, U.S. Food and Drug Administration hearings, with Dimitra Poulos; Amye Leong; Betsy Chaney; John Klippel, M.D., president, Arthritis Foundation; Maj. Christopher Grubb, M.D.; Eileen Lacijan; prepared testimony of Sidney Wolfe, M.D., director, Public Citizen's Health Research Group
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