Sunday, September 16, 2012

BMS-986094 :Trial of hepatitis C drug has deadly outcome

Trial of hepatitis C drug has deadly outcome for area man

Test of experimental hepatitis C remedy turns fatal for area patient, shows risk to volunteers.

The Kansas City Star

When Jessica and Brian Starkey of Leavenworth County were diagnosed with hepatitis C infections last year, they didn’t have insurance coverage for treatment. But Jessica’s doctor said there was still a chance they could get help. Researchers in Kansas City were enrolling hepatitis C patients in a national clinical trial.
They offered powerful drug cocktails featuring a promising new experimental drug to kill the virus. And it was free. The drug, which went by the code name BMS-986094, was among a growing number of experimental antiviral medications being developed to treat hepatitis C, a liver-destroying virus that infects more than 3 million people in the United States and as many as 200 million worldwide.
Any red flags?
Publicly available data on laboratory tests that were run on BMS-986094 before human trials started show that relatively low concentrations of the drug killed human bone marrow cells. Drugs similar to BMS-986094 also are known to be toxic to the kidneys.
But the publicly available information about test-tube and animal tests on BMS-986094, or the preliminary tests on people, remains sketchy. “Was there any signal at all that should have raised a red flag?” asked Michael Carome, a physician and deputy director of Public Citizen’s Health Research Group, a consumer advocacy group involved in drug safety issues.
“We don’t know a lot of important details,” said Carome, who formerly was associate director for regulatory affairs at the Office for Human Research Protections of the Department of Health and Human Services. “I assume they did more studies on animals and did tests of heart and liver tissues. A series would normally be done. The question is what else is out there looking at both short-term and long-term exposure.”

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