Polyheme

More than 250 newspapers covered the advance publication of two Target Articles March 1 at The American Journal of Bioethics' web site [PDF #1, and PDF #2]. On the heels of a somewhat inflammatory news story in the Wall Street Journal concerning the trial of the blood substitute produced by Northfield Labs, the Editors of The American Journal of Bioethics released "An Open Letter to IRBs Considering Northfield Laboratories' PolyHeme Trial" [AJOB 6:3], which became the core of a much more detailed wire service story carrying the title "ethicists object to blood substitute study," that appeared in thousands of television, radio and print news venues.

After reading that story, a Senator made an immediate inquiry that has now come to a boil, as reported in the Washington Post:

The ongoing study of the Northfield Laboratories Inc. blood substitute Polyheme is unethical, officials from the Office for Human Research Protection told the staff of Sen. Charles Grassley, the Iowa Republican said Monday [March 13] in a letter to Health and Human Services Secretary Mike Leavitt.

Grassley wrote Leavitt after a Friday meeting between his staff on the Senate Finance Committee and officials from the low-profile federal agency chartered with ensuring the responsible conduct of research involving humans.

Those officials began raising concerns about the Polyheme trial with their colleagues from the Food and Drug Administration in June 2004, according to Grassley. Both the agency and the FDA, which approved the trial, are part of the Health and Human Services Department.

Office for Human Research Protection officials told Grassley's staff that they would never have approved the Polyheme study, Grassley wrote Leavitt.

Wall Street Journal filed a similar story.

Northfield has responded in a statement to concerns about the study, but, oddly only to concerns expressed in a yet-to-be published study in another journal. Northfield was of course invited to submit an Open Peer Commentary in reply to the two target articles above, but declined to do so. The target articles and commentaries will shortly appear in the print version of AJOB but it is possible to download the target articles alone from the above links immediately.