NEWS: Concerns over drugs jeopardize research

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Concerns over drugs jeopardize research

Rob Stein

Washington Post

Dec. 27, 2004 12:00 AM

WASHINGTON - The spate of bad news about painkillers has dealt a major

setback to what had been a highly promising effort to use the drugs to

prevent a host of leading killers, including many types of cancer,

Alzheimer's and other forms of dementia.

Since concerns emerged that drugs such as Vioxx and Celebrex might cause

heart attacks and strokes, researchers testing the drugs in dozens of

studies have been frantically scouring whatever data they have gathered for

signs of danger, urgently debating whether the trials should continue and

quickly informing participants of possible risks.

Several large studies have shut down fully or partially, including trials

for preventing colon cancer, prostate cancer, Alzheimer's disease and, just

last week, two large international studies evaluating Celebrex to cut the

risk of getting breast cancer or suffering a recurrence. Other studies have

been temporarily suspended until all participants could be warned of the

possible danger.

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Overall, the startling new concerns about the drugs' safety have cast a pall

over what had been one of the most exciting fields of biomedical research,

which was trying to harness important new insights into the underlying cause

of a wide spectrum of illnesses.

" It's definitely been a big setback, " said DuBois of Vanderbilt

University School of Medicine in Nashville. " It's really disappointing

because there had been a lot of enthusiasm in this area, and a lot of trials

were under way. I think this is going to slow things down considerably. "

The developments are particularly distressing because a large body of

evidence indicates the drugs could provide benefits aside from relieving

pain. Even the studies that revealed the possible heart disease and stroke

risks produced evidence that the approach could be highly effective for

reducing the risk for cancer.

Several researchers said they believed the response to revelations of what

are potential risks was an overreaction. The drugs were developed to relieve

pain with fewer side effects than existing painkillers, but researchers

began testing them to treat or prevent a variety of diseases because of

their ability to reduce inflammation, limit cell growth, inhibit the growth

of blood vessels that nourish tumors and, in the case of breast cancer,

lower estrogen levels.