March 14, 2006

US senator demands FDA answers on blood study

By Susan Heavey

WASHINGTON -- A top U.S. lawmaker on Monday called on the Food and Drug Administration to publicly explain benefits of an experimental blood substitute after government advisors said a clinical trial for the product was unethical and never should have been approved.

The Office for Human Research Protections raised concerns about Northfield Laboratories Inc's PolyHeme as early as June 2004, but the FDA failed to respond, Senate Finance Committee Chairman Charles Grassley said.

A series of e-mails and letters showed the office "had a sense of urgency, anxiousness and grave concern" about the study, the Iowa Republican wrote in a letter to Health and Human Services Secretary Mike Leavitt.

Two years' worth of correspondence "suggest a breakdown in dialogue within HHS and an apparent disregard by the FDA to zealously fulfill its mission to protect the public health," he added.

Grassley's letter comes after the protections staff met with his staff on Friday and questioned the design and implementation of the study taking place in 18 U.S. states.

PolyHeme derives from human blood's oxygen-carrying hemoglobin and aims to provide temporary relief when there is a large blood loss and no readily available blood supply.

Under the trial, trauma patients at participating hospitals can unknowingly receive the infused product because of an FDA regulation that waives informed consent as long as a community outreach program is also conducted.

The substitute is not supposed to be tested in certain patients, including pregnant women and those with severe brain injuries, and others can opt out by wearing a special bracelet.

Illinois-based Northfield Labs has said its study met FDA requirements and takes patient safety into account.

Shares of the biotech firm, which had traded above $12, fell after a February 22 Wall Street Journal report said previously unpublished data from an earlier PolyHeme study showed 12 percent of patients suffered heart attacks and two out of 81 patients died.

On Monday, its shares closed at $10.13 on Nasdaq.

Grassley said the agency should not place the burden on the public to opt out. "Equally outrageous is the FDA's apparent failure to ensure that communities are fully aware of the risks, benefits, and nature of this experiment," he said.

In his letter, Grassley urged Leavitt to move quickly to arrange a meeting between the FDA and the protections office. The secretary should also push the FDA to publicly address the risks and benefits of the trial, Grassley wrote.

A representative for Leavitt could not be immediately reached.

On February 23, Grassley asked the FDA for more information about the study but has still not received it, he wrote. FDA officials are scheduled to meet with his staff March 22.

While he does not directly oversee the agency, Grassley's committee monitors the Medicare and Medicaid insurance programs that pay for drugs and other FDA-approved products used by elderly, disabled or poor beneficiaries.