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Deaths Decline in Drug Studies

Posted on: Thursday, 4 November 2004, 03:00 CST

CHICAGO - Patient deaths from experimental cancer drugs during initial human studies declined dramatically from 1991 to 2002, suggesting that better oversight and less-toxic medicines have made cancer research safer, a study found.

There were 35 drug-related deaths in the 213 studies examined, but such deaths were much more frequent in the earlier experiments than in the more recent ones.

There were 24 drug-linked deaths in studies from 1991 to 1994, 10 from 1995 to 1998 and only one from 1999 to 2002.

Deaths from other causes, including cancer, decreased, too - from 39 to 17 in the more recent studies.

Mace Rothenberg, a Vanderbilt University cancer research specialist who was not involved in the study, called the findings "clearly good news."

"It indicates that patients who agree to go on to these fairly risky studies are not placing themselves at an unacceptably high risk for severe toxicity or death," he said.

The studies involved a total of 6,474 patients, and the overall death rate fell from 3 percent to 1 percent.

At the same time, there was also a decline in the percentage of tumors that shrank in response to the drugs being tested. But the researchers and other cancer experts said that does not mean the drugs were increasingly ineffective.

Some of the newest cancer drugs employ a more targeted approach than older medicines, attacking tumor cells while causing less damage to healthy tissue. These drugs often work by stopping but not necessarily reversing tumor growth, said Thomas Roberts Jr. of Massachusetts General Hospital, the study's lead author.

Source: Augusta Chronicle, The

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