September 3

Vera Sharav: A Profile in Nature Biotechnology

In contrast, Arthur Caplan, chair of the department of medical ethics at the University of Pennsylvania in Philadelphia, views Sharav as a dangerous gadfly. "She’s best on the subjects she knows something about, like psychiatry, which she hates," he says. "But when she attacks efforts to find better therapies for emergency situations [e.g., blood substitutes], she causes real harm and she risks killing people…"

The author of the profile failed to inform Nature readers that Arthur Caplan’s criticism may not be objective. Caplan’s academic institution was one of the medical centers that approved Northfield Laboratories’ non-consensual artificial blood expreriment–U of Penn had a financial stake in this ethically dubious, widely criticized, experiment.

The experiment was conducted on unconscious trauma patients–even after an earlier trial with consenting patients who underwent elective surgery, was suspended when 10 out of 81 patients suffered heart attacks within a week of receiving the substitute, PolyHeme, and that 2 of those people died.

On February 22, 2006, The Wall Street Journal reported that in addition to the heart attacks and deaths, the trial suggested that PolyHeme was linked to other adverse events such as heart rhythm aberrations and pneumonia. These events occurred in 54% of the PolyHeme patients versus 28% in the control group, according to Northfield’s internal documents.

See: Red Flags: Amid Alarm Bells, A Blood Substitute Keeps  Pumping By THOMAS M. BURTON; Page A1

On February 24, 2006, Senator Charles Grassley, chairman of the Senate Finance Committee wrote to FDA Commissioner, Dr von  Eschenbach: 

"It is outrageous that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes every citizen in the United States a potential "guinea pig," without providing a practical, informative warning to the public."

Click here for full Sharav profile in Nature Biotechnolgy

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