June 26, 2006

Northfield Goes on Record on Polyheme Issues

The current issue of AJOB is making news daily, as one community after another asks questions about research where there is no possibility for informed consent (in many cases). Everyone wants to know why community consultation for resuscitation research seems to be so difficult, and why in the absence evidence of good community notification, IRBs let studies proceed. AJOB devotes an entire issue (the first ever in bioethics) to the issue, and it is filled with commentaries and articles that constitute a cookbook for sponsors of these trials, in the vague hope (in many authors' minds) that sponsors will be able to emerge from a kind of weird denial in order to save themselves from the PR catastrophes they continue to create for themselves.

You'd think that Northfield Labs (the sponsor/owner of PolyHeme) would have something thoughtful to say about how that company, in the middle of a tornado, will be dealing with the matter, particularly when the company representative is being interviewed for an article by Gannett News Service that ran not only in USA Today but in dozens of other papers about the matter.

Nope, he proposed nothing, no committee, no ethics team, no refinement of materials, and still no answers of consequence to the charge made by Penn researchers and later by Johns Hopkins itself, that there was a coverup of material that should have been published. No comment of consequence even when the Johns Hopkins researcher the company had said would clear everything up was subsequently denied - just a few months ago - the data he needed to give that speech.

You'd think Northfield would want, in the face of all this controversy, to resolve any doubts that might otherwise need to be shared with the community. But instead the company seems to have a zero ethics plan:

“Is this a good reg? Is it perfect? Can it be better? Can it be worse? Those are important policy questions that we feel we can and should address,” says Steven Gould, chief executive of Northfield Laboratories, the firm that makes and is studying PolyHeme. “To do research without prospective informed consent defies what we would all say is good ethical practices, so you have this conundrum.”
Yes. So you will be doing what? Asked by this journal to respond to the King article, Northfield refused. Asked to participate in a discussion with PIs of the trial about how to refine community consultation so that communities can understand the ongoing issues that are in articles like this one, the company offered to consider the idea then didn't reply. Asked whether they would like to try to convene an ethics review, board, study or to participate in any other review of the associated issues with others, there was no reply.

The conundrum is there, no question. But it isn't about the ethics of research without informed consent, or about their failure to respond adequately (in the minds of many) to charges that their study is designed so that it intentionally requires that subjects receive Polyheme instead of blood even after they arrive in hospitals (and without consent), contrary to the standard of care.

No, the the conundrum is how Northfield will manage to avoid killing off resuscitation research entirely, while sitting in wait for a Senator who is mad as hops. Somebody please wake these guys up.

[update]Or on the other hand, if the greed boys have it right, none of this will matter and within days there will be Polyheme in every healthcare facility in the nation. Ah, markets.

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