August 02, 2006

A Bloody Mess

In this month's The Scientist McGee opines about the trials (recently completed) of blood substitutes under the Final Rule, which allows for research without consent. It is a subject we've written about in the past, and as part of our ongoing research in the area we devoted a special issue to the trial in The American Journal of Bioethics, specifically an article entitled "Accidental Communities: Race, Emergency Medicine, and the Problem of PolyHeme and another entitled "An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial," along with many commentaries on those two articles.

As everyone knows by now the publication of the AJOB issue resulted in a huge amount of scrutiny of the trials, which continues, though the trial has now officially been completed.

Here's part of the essay, a reflection on the whole matter:

... Oxygen-carrying blood substitutes have been tried for years on consenting research subjects with mixed results, but enough hope has existed that since 1970, no fewer than three companies have fixed their sights on making one. And now Polyheme's sponsor and manufacturer, Northfield Labs, hopes it is just steps away from approval for use on the battlefield or in a trauma helicopter near you. So with what could amount to a significant advance for trauma medicine being on the brink of approval, why are the airwaves, newspapers, academic journals, and magazines riddled with stories about whether research subjects in the trial are human guinea pigs?

The answer is that the community has been caught off guard. In Phase I and Phase II trials of Polyheme, all subjects were required to give informed consent. Eventually, however, Polyheme had to be tried on typical patients who would benefit from artificial blood: victims of trauma. Regulations passed in the mid-1990s called the Final Rule allow such research, provided a list of precautions is followed, including something called "community consultation." The idea is that while enrollees would be too ill to consent, investigators would have informed the community about the trial in advance; anyone who doesn't want to participate can prospectively opt-out by, for example, wearing an armband.

In the current trial, after informing the community about Polyheme, emergency medical technicians randomly administer either saline solution or Polyheme to trauma patients who are in hemorrhagic shock. The control group receives blood, the standard of care. Those randomized to Polyheme receive it for no more than 12 hours; part of that time may be in the hospital when they would otherwise be given blood.

The problem is that most people in the communities where Polyheme trials are going on, from Illinois to North Carolina to New York, don't seem to know about it. Emergency medical research is a bloody mess right now because Polyheme, once unknown to potential subjects, is suddenly on the public radar, but only because of concerns that include undisclosed or inappropriate risks to subjects in the in-hospital phase of the study, worries about whether the sponsor has withheld data from investigators, and now new criticisms from organizations such as the Senate Appropriations Committee and consumer advocacy groups.

Our bioethics institute studied public awareness of the Polyheme trial ... It has become clear, at least to my group, that patients worry about emergency research, and that new methods for informing the community must be devised and tested before proceeding with trials that have such potential to destroy public trust in research ...

[read the entire piece]

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