US senator questions FDA-approved blood study

WASHINGTON (Reuters) – A key Senate Republican pressed the
U.S. Food and Drug Administration on Thursday for details on
its role in the clinical trial of an experimental blood
substitute being tested on trauma patients in 18 states, in
some cases without their consent.

Senate Finance Committee Chairman Chuck Grassley asked the
FDA to make a full public disclosure about the clinical trial
of Northfield Laboratories Inc.’s PolyHeme blood substitute,
after its safety was called into question in a Wall Street
Journal article.

“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,” the
Iowa Republican said in a letter to acting FDA Commissioner
Andrew von Eschenbach.

The Wall Street Journal reported on Wednesday that
Evanston, Illinois-based Northfield was conducting the trial
under a rarely used FDA regulation allowing waivers of the
informed consent typically required in clinical trials —
provided the trial is accompanied by a community outreach
program.

The article described a previous clinical trial of
PolyHeme, in which about 12 percent of patients on the product
suffered heart attacks and two out of 81 patients died. The
trial results were not published, the newspaper said.

Northfield said on Wednesday it had disclosed full data
from that trial, which closed in 2000, to the FDA. The company
said publishing the data would have shown PolyHeme could not be
isolated as the cause of the serious adverse events that were
observed.

Last April, the company said an independent safety panel
gave the green light for its late-stage testing to continue,
after a review of death rates in the study.

In his letter to the FDA, Grassley expressed concern that
patients could be subjected to the experimental blood product
unless they were wearing a wristband that says they decline to
participate in the study.

Many people probably do not know how to get the wristband,
he added.

“Why should Americans have to wear a bracelet at all times
to protect themselves from a government-sanctioned medical
experiment if they happen to get into a car accident?” Grassley
asked in a statement releasing the text of his letter.

Grassley asked the FDA to provide his committee with a
detailed briefing on the PolyHeme study no later than March 8.
His panel has oversight of the Medicare and Medicaid programs,
which pays for drugs and other FDA-approved products used by
old, disabled or poor beneficiaries.

An FDA spokesman did not immediately respond to an e-mail
request for comment.