kristen butler is seeing racism where there is none and missing the bigger picture of poor ethics behind many clinical trials, this one being polyheme.

Quote :

"9/1/06 Bloody Hell With all deliberate speed Kristen Butler Last week I promised to bring you specific instances where Duke is treating Durham residents in ways that may be racist or elitist. Today's installment's topic reflects both. In March 2006, the Duke University Hospital resumed a controversial "waived consent" clinical trial of a blood substitute called PolyHeme. Under the trial's guidelines, paramedics will administer PolyHeme--without consent--to patients who are "critically injured, losing a large amount of blood and in shock." These trauma victims will continue to receive PolyHeme at the hospital--again, without having consented--for 12 more hours, despite the fact that real blood, which is the universal standard of care, is available. PolyHeme, which is made from human blood, may be better than the saline given in the field because it contains oxygen-delivering cells; it is also compatible with all blood types, and it can be easily transported in an ambulance. PolyHeme is experimental, however, and researchers do not yet know if it works as well as real blood. Indeed, there are two serious problems here. The first: PolyHeme may not be safe. The second: Duke Hospital's new ethical model, which considers "community consultation" an acceptable substitute for an individual's informed consent. The Wall Street Journal recently published an article questioning why Northfield Laboratories, the maker of PolyHeme, withheld troubling results about the performance of its only product. So how did the blood substitute perform when given to people recovering from heart problems? Of 71 patients who received PolyHeme, 10 had heart attacks and 2 died. Of 81 who got human blood, 0 had heart attacks. If you count other "adverse events" like pneumonia and arrhythmia, the results are even worse: 54 percent of PolyHeme recipients had these problems, versus 28 percent of the control group. Consider, then, the objectivity of this pamphlet from the INOVA Health System, which is also testing PolyHeme, reassuring participants that "PolyHeme has demonstrated no clinically relevant adverse effects." Whether or not PolyHeme ultimately proves safe and effective, the manner in which it is being tested is unprecedented. In fact, Duke initially had to suspend the study when it became clear that "community consultation" protocols were illegal under North Carolina law; the study only resumed after Duke had successfully lobbied the North Carolina General Assembly for an amendment to this state's Patient's Bill of Rights. What's worse, an article in The American Journal of Bioethics recently asserted that the PolyHeme study is designed to artificially simulate "the circumstances of combat-wounded soldiers when evacuation to field hospitals is impossible." This explains why doctors are required to continue administering PolyHeme for 12 hours in the hospital, since "12-hour field evacuation delays" represent "well-known military constraints." Indeed, it is worth noting that the bioethicists writing the article ultimately conclude that the PolyHeme trials "cannot justify a possible departure from ethical principles governing research on non-consenting civilian human subjects." Given the legacy of slavery, segregation and discrimination in this region-and in this hospital--it is particularly disheartening to consider the racial overtones of a "waived consent" clinical trial. Historically, physicians have shown an appalling disregard for the rights of racial and ethnic minorities, particularly when conducting experimental research. Given the importance of that cultural narrative to a county that is almost 40 percent black, Duke Hospital's decision to appropriate unconscious patients for use in this study reopens old wounds. Indeed, PolyHeme's most serious "adverse effect" of all may be the damage it does to the bond between physician and patient, particularly in communities already inclined to distrust Western medical practice. After all, why should you trust a doctor who asserts his right to experiment on your body without consent, no matter how exceptional the circumstances? I lived no more than 1,500 feet from an entrance to Duke Hospital for my entire sophomore year, and so I would like to assure bioethicists and administrators alike that my "community" was never "consulted" when this protocol was approved. In fact, I would be shocked if 2 percent of Duke students had ever heard of PolyHeme before today. Given that the "traumatic injuries" targeted by this study represent the number-one cause of death for our age group, this is completely unacceptable. Of course, this column is ultimately about much more than a blood substitute, or even the dubious way in which it is being tested. This is also a conversation about institutional authority, and the ways in which we choose to wield it. Keeping in mind that many Durham residents interact with our campus primarily through treatment at the Duke Hospital, this community has a decision to make: if we do not want to be called racists or elitists, then will we address the latent indignities that invite those charges? Kristin Butler is a Trinity junior. Her column runs every Friday."

while she makes good points, she misses the mark and goes for the attention grabbing racial by-line....



http://tinyurl.co.uk/ky5z

9/1/2006 12:42:06 PM

Hooray for sensationalist journalism. Objective reporting would have been a lot more in-depth, gathering multiple viewpoints and talking with figures from all sides for facts, explanations, etc. She'll make a fine career at somewhere like CNN.

And link plz.

9/1/2006 1:02:45 PM

at the bottom

9/1/2006 1:04:07 PM

I saw nothing in there that said that Duke was only giving black people this PolyHeme.

9/1/2006 1:07:30 PM

^^
Dur, thanks.

9/1/2006 1:11:47 PM

words

9/1/2006 1:26:57 PM

Quote :

"I saw nothing in there that said that Duke was only giving black people this PolyHeme."

exactly

she leads off her article like this

Quote :

"Duke is treating Durham residents in ways that may be racist or elitist. "

and then only has a population % to back it up....

very weak

9/1/2006 1:36:27 PM

Horrible journalism. I can't believe any editor would let shit like this get out to the public.

9/1/2006 2:27:38 PM

although she's totally off her rocker to use the race card, i wish we had more people with her kind of writing skill at Technician.

9/1/2006 2:32:29 PM

Quote :

"I lived no more than 1,500 feet from an entrance to Duke Hospital for my entire sophomore year, and so I would like to assure bioethicists and administrators alike that my "community" was never "consulted" when this protocol was approved. In fact, I would be shocked if 2 percent of Duke students had ever heard of PolyHeme before today. Given that the "traumatic injuries" targeted by this study represent the number-one cause of death for our age group, this is completely unacceptable."

OMGWTFBBQ RACIST! DUKE HATES WHITE PEOPLE!

9/1/2006 2:34:48 PM

your completely off on this one Arab13.... yes she says

Quote :

"Last week I promised to bring you specific instances where Duke is treating Durham residents in ways that may be racist or elitist"

but you are doing exactly what your accusing her of doing.... concentrating on something that’s not the point.

In that she says that but the entire article is about consent of a community, and barely mentions the racial aspect. she, in my opinion didn’t miss the point at all and address the point you want her to address relatively well..... on the whole this was not a piece off topic rather did exactly what you wanted it to do... address the ethical practices of clinical trials...

9/1/2006 2:42:08 PM

THEY NAMED DUKE AFTER DAVID DUKE!

9/1/2006 3:26:22 PM

Quote :

"but you are doing exactly what your accusing her of doing.... concentrating on something that’s not the point. "

aha, not really, i don't care, the point is that Duke hospital will be using this polyheme without consent as a part of a medical trial

like I said in my post (if you bothered to read it all) the bigger issue (indeed only one as far as i am concerned) is the poor ethics involved in this decision.

Quote :

"Given the legacy of slavery, segregation and discrimination in this region-and in this hospital--it is particularly disheartening to consider the racial overtones of a "waived consent" clinical trial. Historically, physicians have shown an appalling disregard for the rights of racial and ethnic minorities, particularly when conducting experimental research. Given the importance of that cultural narrative to a county that is almost 40 percent black, Duke Hospital's decision to appropriate unconscious patients for use in this study reopens old wounds."

did you miss this part or somthing?

[Edited on September 1, 2006 at 3:42 PM. Reason : e]

9/1/2006 3:41:33 PM

^ Uhh, if you had read previous news about Polyheme, you would find out that they did receive consent in a series of town-hall meetings.

Quote :

"Federal regulations require "waiver of consent" study investigators to hold public meetings to educate the community in which the trial is to be conducted; answer questions from the community about the study; and obtain feedback from citizens regarding the proposed clinical trial. Public meetings to discuss the PolyHeme study were held in Durham over several weeks last summer. According to the investigators, the proposed study met with majority approval by citizens who attended the meetings. People who do not wish to participate in this clinical trial -- should they experience traumatic injuries -- can opt out of the study by obtaining an "opt out" bracelet from Duke. To opt out, they should send a letter to Dr. Steven Vaslef, DUMC Box 2601, Duke University Medical Center, Durham, NC, 27710, or contact Angela King at 919-668-8686, or via email at: king0037@mc.duke.edu. Please specify "PolyHeme" or "Opt Out" in the subject line. "

So, I would say, if you hadn't heard about the consent, it's your own fault for not being an informed citizen of the community. Same goes for her 2% of Duke students, believe it or not they're just like any other college student and are more concerned with beer and sex than with community events. GASP

9/1/2006 7:57:59 PM