Northfield defends controversial US blood study

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)