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Northfield defends controversial US blood study

Posted on: Friday, 24 February 2006, 16:58 CST

WASHINGTON (Reuters) - The maker of an experimental blood substitute defended its controversial study on Friday, one day after a senior Republican lawmaker questioned testing of the product on some trauma patients who could not give consent.

Northfield Laboratories Inc. said a late-stage trial PolyHeme blood substitute met the U.S. Food and Drug Administration's requirements and, after talks with the agency, would continue as planned.

The trial, taking place among in 18 U.S. states, is being conducted "with utmost concern for patient safety," the Evanston, Illinois-based company said in a statement.

Still, Northfield shares closed down 6.73 percent, or 76 cents, at $10.54 on Nasdaq.

Senate Finance Committee Chairman Charles Grassley on Thursday asked the FDA to make a full public disclosure about the clinical trial after its safety was questioned in a Wall Street Journal article.

The newspaper earlier this week reported the company was conducting its study under a rarely used FDA regulation that allows waivers of informed consent usually required in clinical trials as long as the trial is accompanied by a community outreach program.

Grassley, an Iowa Republican, pressed the FDA for more details on the agency's role in allowing the study. His committee oversees the Medicare and Medicaid insurance programs that pays for drugs and other FDA-approved products used by old, disabled or poor beneficiaries.

Northfield spokeswoman Sophia Twaddell on Friday said the FDA, not the company, was the target of the senator's probe. She did not know if the FDA had contacted the company over the inquiry.

An FDA spokeswoman could not be immediately reached for comment. Representatives for Grassley also had no immediate comment.

(Additional reporting by Kim Dixon in Chicago)

Source: REUTERS

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