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The Wonders of Polyheme...By Press Release

In the time since my research group published numerous articles concerning community consultation in the trial of the oxygen-carrying blood substitute Polyheme, particularly the most recent trial, conducted in a number of institutions (all Level I trauma centers), Polyheme has been subjected to more criticism than any other substance ever tried under the FDA's special exception allowing some research to be conducted without informed consent. Johns Hopkins published a press release decrying the company's failure to release data and announcing its opinions about the Northfield Laboratory's Phase II study, which preceded the Trauma Centers trial, in which stroke patients received polyheme. Yet for all the scrutiny, Northfield soldiers on. Soldiers - really - because that is the market for which Polyheme and its ken were designed from the start, the military at war, where a blood carrying substitute that doesn't provoke an immune response and keeps a patient's tissues oxygenated would be miraculous.

But a funny thing keeps happening, and nobody seems to care, or at least not enough to kill the continuing trials or even slow them down. My own group's study at Albany Med - a phone study of more than ten thousand residents of that metro area - found that essentially no one knew anything about the trial or the substance, and another study found that those who were presented with the possibility that they might get the substance were quite adamant that they would not want to be involuntarily enrolled - if at all. Criticism of Polyheme in the special issue of The American Journal of Bioethics was covered, well, pretty much everywhere [click on that link to find copies of the AJOB articles as well], and Senator Grassley literally convened a meeting with FDA officials to discuss the special issue of AJOB, which was just a wee bit discomfiting for those of us who had worked on the issue while in an institution conducting the trial...

Nonetheless, the trials continue...after countless efforts by everyone - bioethicists, IRBs, patient activists, journal editors (other than myself), and plenty of ED docs, including those in several trauma centers who cancelled the trials long before some of us were able to get our own institutions to stop. And that brings me to the point...a quick check of Wikipedia's entry today on Polyheme revealed what a quick check of the literature confirms...to this date, despite all the obvious issues with a clinical trial that has had at best disappointing results, given the trade-off of informed consent and the vulnerability of the subject population, continues to do its publishing of clinical findings by...press release. It's a bloody shame. The FDA must amend the subsection of its rules that allows an exception from informed consent requirements, at a minimum, so that those who conduct such trials not only have to tell the communities who end up participating in the survey about the outcomes, but also have to publish their findings in real journals.

- Glenn McGee, PhD