INDIANAPOLIS, Sept. 8, 2013 How many breakthrough new drugs never reach patients because tests in clinical trials suggested a high risk of liver damage when the drug actually was quite safe?
That question underpins major international research efforts to modernize tests for drug-induced liver injury, mentioned here today at the 246th National Meeting & Exposition of the American Chemical Society (ACS), the world's largest scientific society. The meeting, which features almost 7,000 reports on new discoveries in science and other topics, continues through Thursday in the Indiana Convention Center and downtown hotels.
Paul B. Watkins, M.D., who made the presentation, explained that drug-induced liver damage is a rare drug side effect, but so serious the No. 1 cause of sudden liver failure that it has a disproportionate impact on a drug's fate. Liver toxicity is also the No. 1 safety concern causing pharmaceutical companies to halt development of new medicines sometimes after spending hundreds of millions of dollars on clinical trials to establish the drug's safety and effectiveness. Likewise, it is the leading reason why drugs already on the market must be restricted or banned.
"Blood tests used today in clinical trials for assessing liver safety are the same ones we've used for at least 40 years," said Watkins, referring to tests that measure substances released into the blood when liver cells die. "The tests do indicate damage to liver cells, and everyone assumed over the years that a positive result raised a red flag about a drug's safety. We now know, however, you can have abnormalities in these tests even pretty remarkable ones with drugs that pose no serious threat of damaging the liver."
Watkins described research, done with colleagues at the Hamner-University of North Carolina Institute for Drug Safety Sciences, in which healthy volunteers took prescription and non-prescription medicines that have been in use
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