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AIDS drug sparks concern.

AIDS drug sparks concern

In some patients, the experimental AIDS drug dideoxyinosine (DDI) appears to increase the risk of death from pancreatitis, an inflammation of the pancreas. Researchers expressed concern about the link last week after DDI manufacturer Bristol-Myers Squibb Co. of New York City said six AIDS patients taking DDI had died of pancreatitis and that five of those were enrolled in a federally approved program that allows widespread distribution of DDI.

About 8,000 people with AIDS took advantage of the Food and Drug Administration's decision last fall to approve the expanded-access program, which allows Bristol-Myers Squibb to provide DDI to severely ill AIDS patients who fail to qualify for clinical DDI trials (SN: 10/7/89, p.231). Participating patients get DDI from private physicians who agree to inform the manufacturer of any problems. Now Bristol-Myers Squibb reports 290 deaths out of 8,000 people enrolled in the program, with five of those deaths due to pancreatitis, says spokeswoman Kathryn Bloom. In contrast, the company reports two deaths (one due to pancreatitis) among the 700 AIDS patients enrolled in Phase II clinical trials.

"Bad news like this makes you want to look more closely at how [the access program] is being administered," says Jeffrey Laurence of the Cornell University Medical College in New York City. Bloom contends the higher overall death rate among expanded-access patients stems from the severity of their illness upon entering the program.
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Title Annotation:dideoxyinosine
Publication:Science News
Date:Mar 17, 1990
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