Word: vioxx
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Heart attack, stroke or cancer. Take your pick. That was the choice I was being offered, or so it seemed. I'm one of hundreds of patients who were participating in clinical trials to investigate whether COX-2 inhibitors such as Celebrex and Vioxx, commonly used as anti-inflammatory drugs, are also effective in fighting or preventing cancer. But the trials were halted last year after reports that the risk of heart attack or stroke doubled among a group of Vioxx users. Vioxx was summarily yanked from the market and the tort lawyers immediately canceled lunch. Celebrex was also implicated...
...Vioxx news was disappointing and upsetting, because it sidetracked what scientists believed--and I had come to hope-- was a promising avenue of research. That promise was underscored by several papers presented at the annual meeting of the American Society of Clinical Oncology (ASCO) last week, including one out of UCLA Medical School that showed that Celebrex, used in combination with newer cancer drugs, was successful in treating patients with late-stage lung cancer. In 9 out of 15 patients whose prior treatments had failed, the Celebrex cocktail either stopped the disease from progressing or shrank their tumors. In cancer...
Ironically, the trial that exposed the heart risks of COX-2 inhibitors was a cancer experiment, designed to test whether Vioxx or Celebrex could prevent the recurrence of colon cancer. It was halted before any conclusion could be reached. The situation was even more frustrating for patients in a second trial. There, scientists did indeed find a lower recurrence of colon tumors in patients taking Vioxx. "There was a reduction in adenoma recurrence," notes the study's lead author, Dr. Robert Bresalier of MD Anderson Cancer Center. "How that balances with the potential risk remains to be seen...
...pressure for action grew so intense by last week that the FDA was forced to take action. On the eve of an extraordinary three-day hearing to air grievances resulting from the Vioxx and Celebrex snafu, it announced plans to create a new safety board to monitor drugs for unexpected side effects that show up after the drugs have gone on sale. Meanwhile, the Bush Administration finally moved to fill a one-year power vacuum at the top of the organization by nominating its acting chief, Dr. Lester Crawford, to be the FDA's permanent head...
...used by large numbers of people, turn out to be the rare ones. Most doctors don't see very many cases of liver failure, for example. So they notice right away if more and more of their patients get hospitalized for it. The problem with COX-2 inhibitors like Vioxx is that they increase the risk of two very common ailments: heart attacks and strokes. It's much harder to tell, without careful statistical analyses, when common events become more common. "The [drug-approval] system was tested in ways it was never tested before," says Dr. Eric Topol, chairman...