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
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.