More Upsetting News About Irritable Bowel Treatment
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Still, Carter cautions physicians and patients to take the time to determine whether Lotronex truly is the appropriate treatment. Clinical studies have shown Lotronex greatly benefits women, with about 75% reporting a significant improvement in their symptoms over 12 months, but the drug is not indicated for any men or for women whose predominate IBS symptom is constipation, he tells WebMD.
"It is not the mandate of a pharmaceutical company to tell a physician how to practice medicine. Quite frankly, no one can do that," he says. But while the company is reluctant to question the clinical judgement of physicians, the recent reports do demonstrate that the drug is being prescribed inappropriately to some patients, including patients with a history of severe intestinal disease, he tells WebMD.
To address this particular issue, the company is launching an advertising campaign aimed at consumers to help them determine whether Lotronex is appropriate for them. Despite Glaxo's actions, the controversy surrounding Lotronex is unlikely to die anytime soon.
Because IBS is a difficult condition to diagnose, it is possible that a number of the patients prescribed Lotronex do not even have the condition, Public Citizen says. "We don't think it should have been approved in the first place," Larry Sasich, PharmD, MPH, the group's lead researcher, noted in a recent interview with WebMD.
About 70-80% of patients prescribed Lotronex potentially are being exposed to the risk of ischemic colitis without enjoying any medical benefit, FDA officials also noted previously. This figure comes from clinical trials, which indicate that about 80% of the people who participated in the trials either failed to improve or improved due to other reasons, said Florence Houn, MD, director of the FDA's office responsible for intestinal drugs.
But the argument goes both ways. Other experts say that drugs like Lotronex are needed desperately, even though IBS is not a life-threatening condition.
Prior to the approval of Lotronex in February 2000, physicians recommended psychiatric treatment or a change in lifestyle as ways to treat IBS. But to assume that these treatments are sufficient is to ignore a major quality-of-life issue that can be debilitating, Harris Clearfield, MD, a professor of medicine at Hahnemann University Hospital in Philadelphia, recently told WebMD. "I would also take issue with the notion that IBS is often misdiagnosed," he said.