Celebrex Doubted

For Halting Ulcers

The arthritis drug Celebrex does not protect the stomach from dangerous bleeding ulcers as well as was thought, a study suggests.

Celebrex and two similar new anti-inflammatory drugs -- Vioxx and Bextra -- are advertised as being safer for arthritis patients, based on research that found they caused fewer ulcers and other gastrointestinal complications than older anti-inflammatory medicines. Together, the three drugs have annual sales exceeding $6 billion.

But their safety has been called into question. The new study, which focused on arthritis patients at high risk of recurrent ulcers, escalates the controversy involving Celebrex, showing nearly 10 percent each year would develop another bleeding ulcer.

The study found the same thing for an older anti-inflammatory drug combined with ulcer medicine Prilosec, which doctors often give arthritis patients to protect their stomachs. Neither treatment protected as many patients from kidney complications as past studies showed, the researchers said.

The Hong Kong researchers and other experts said the results, while showing the treatments work the same, indicate more study is needed on preventing bleeding stomach ulcers in people who treat joint pain with nonsteroidal anti-inflammatory drugs, or NSAIDs.

The study, reported in today's New England Journal of Medicine, included 287 patients with a bleeding ulcer and so were at high risk of developing another, potentially life-threatening, ulcer.

Half took the anti-inflammatory diclofenac together with Prilosec; half received Celebrex. Of the study patients receiving Celebrex, about 5 percent had recurrent bleeding during the six months of research, compared with about 6.5 percent for those getting diclofenac and Prilosec.

That equates to annual rates of about 9 percent and 11 percent, respectively, David Y. Graham of the Veterans Affairs Medical Center in Houston wrote in an accompanying editorial. "The results were unexpected: Neither regimen provided a good or even acceptable level of protection from recurrent bleeding," Graham wrote.

Consent Forms Get Backing From Study

While cancer patients participating in studies of experimental drugs may mistakenly expect benefits without risks, it is probably not because of the consent forms, federal researchers say.

Their study found the forms nearly always say the goal is to test the medicine's safety, not to help patients.

"If there is a misunderstanding . . . there's probably another reason," such as patients' desperate hopes, said lead researcher Christine Grady of the clinical bioethics department at the National Institutes of Health's Warren G. Magnuson Clinical Center.

Her review of 272 consent forms was reported in the New England Journal of Medicine.

It showed that less than 5 percent of forms said a cure was possible, while about 80 percent stated that severe or permanent harm was possible; about two-thirds mentioned death as a risk.

Grady said the main problem is that forms repeatedly used the word "treatment" without saying it is "experimental."

-- Compiled from reports by the Associated Press