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Some drugs can fight symptoms, but not litigation

Street Smarts. By Scott Gottlieb, MD, amednews contributor. Sept. 10, 2001.

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STREET SMARTS

A column looking at the corporate side of health care

SEE ARCHIVES

You've seen them in your office. They can't take a trip to the mall without mapping bathrooms. Long road trips are out of the question.

An estimated 50 million people suffer from irritable bowel syndrome. Some are literally confined to their homes for fear stool can spill at any moment. When a potent treatment finally came along last year, thousands of these affected patients were understandably relieved.

In the first nine months, more than 300,000 patients received the drug, called Lotronex (alosetron hydrochloride). Many had a dramatic resolution of their symptoms. Of course, like most drugs, the chemical was not completely benign. The Food and Drug Administration warned that it could cause rare complications, so dosages were carefully regulated, and warnings were placed inside the carton.

Even the most ordinary medicines can sometimes be extraordinarily hazardous. Aspirin often causes dangerous bleeds, and a single dose of an antibiotic sometimes kills. When a powerful drug is administered to thousands, a few are bound to have a bad outcome.

In the case of Lotronex, about four dozen patients were said to have suffered ischemic colitis, and three patients on the drug died. Never mind that many of these patients had reportedly misused the drug or that the condition is already known to occur spontaneously in the drug's target population.

Never mind that two of those who died reportedly passed away weeks after discontinuing the medication, or that one of them had apparently only been on the drug for a few days. [...]