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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Are you aware of this detailed comment on the matter?
http://www.bioethics.net/journal/j_articles.php?aid=998
Are you aware of the research showing that blood given in large quantities can kill people from Multiple Organ Failure (MOF), and to investigate that aspect is one of the purposes of the current trial? (I would prefer that I or a loved one of mine get Polyheme in the hospital over blood.)
Are you aware of the published trial on 171 Jehovah's Witnesses, which was the basis for the current trial, where some patients had virtually no blood left but were able to survive on Polyheme, with a temporary rash as the main side effect?
Are you aware that Dr. Gould of Northfield Laboratories and Dr. Moore of Denver Health travelled to Washington to meet with the "mad as hops" Senator's staff on the subject?
Are you aware that at any time, before or within the hospital, the patient or any one representing the patient can discontinue participation in the trial?
Finally, are you able to consider the possibility that for use in trauma blood may be inferior to Polyheme, and that Polyheme might just be the greatest advance in trauma medicine since the introduction of saline in World War I?
(I have no affiliation whatever with Northfield Laboratories or this trial.)
- by jeff b on Jun 26, 2006 at 12:57 PM | link
As to your first two paragraphs, yes. Quite aware. Look, I'd take polyheme in a minute. And give it to all the people I know. That is not the issue. That it is doing just dandy in the materials you've read isn't the point. The point is that hiding information from investigators, then this nonsense with the Hopkins guy, then the attempt to silence a newspaper, then the duck-and-cover refusal to do any additional community consultation so that the community is aware of the additional issues - even if you (as an investor, posting on the Yahoo Finance board) don't think they are significant. See, there's this law. It's called the FINAL RULE. When you've read it, get back to me.
As for the notion that anyone can say no, or pull out, duh. Everyone knows this. It is not the issue.
Is polyheme the best thing since saline? Hmm, I donno Jeff, what do the folks over at your board say?
As best I can tell, the numskulls on the board think that the ethicists are sad that nobody from Northfield called them back. Uh, oops, no. Actually the ethicists have been pretty much nonplussed by Northfield. But as you watch during the next couple of months, let us know how you feel about the idea that Northfield should just ignore entirely the problem of community consultation - see how that works for your stock value. Let us know. We ethicists may not really understand but we'll stretch.
- by Reply on Jun 27, 2006 at 6:39 AM | link