Archive for Tuesday, January 10, 2006

Blood substitute available in area

Six ambulances carrying PolyHeme, which will be used for critical patients

January 10, 2006

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An experimental blood substitute has been delivered to Douglas County ambulances and is ready to be pumped into emergency patients, but a similar trial in California has sparked criticism and legal battles.

"If this really works, this will revolutionize the treatment of patients with hemorrhagic blood loss due to trauma," said Jim Murray, support services division chief with Lawrence-Douglas County Fire & Medical.

PolyHeme has been placed on six area ambulances - five in Lawrence and one in Baldwin. It will be administered to qualifying, critically-injured trauma patients. The blood substitute also will be used in Leavenworth and Wyandotte counties.

PolyHeme, developed by Northfield Laboratories Inc. and used in several study sites across the country, has seen its share of problems and controversy. In California, the weekly San Diego Reader is battling the company over the publishing of details about the project. Northfield representatives say the paper is trying to publish "trade secrets" contained in public documents.

A concern, according to Richard Spirra, the newspaper's attorney, is that PolyHeme is tested on people without their consent.

According to articles printed in the Reader, the newspaper found that the trials in San Diego targeted the neighborhoods of poor and minority residents "unlikely to have heard of the study and unlikelier still to have the resources to sue if something goes awry."

Lawrence-Douglas County Fire & Medical paramedic Lt. Zane Morgan holds a unit of PolyHeme, a synthetic blood that is in trials across the country and is being carried in six of the department's ambulances. The product carries oxygen that could be of great benefit to trauma victims.

Lawrence-Douglas County Fire & Medical paramedic Lt. Zane Morgan holds a unit of PolyHeme, a synthetic blood that is in trials across the country and is being carried in six of the department's ambulances. The product carries oxygen that could be of great benefit to trauma victims.

Scott Robinson, an emergency room doctor at Lawrence Memorial Hospital and the medical director for Lawrence-Douglas County Fire & Medical, said similar problems won't occur here.

"Informed consent is such a part of our society that everybody is very sensitive to it," he said.

Is it beneficial?

PolyHeme is a human hemoglobin-based oxygen-carrying substitute.

Emergency responders currently use saline to quickly replace blood lost by trauma victims during emergencies. Carrying blood in ambulances is too difficult because it has a relatively short shelf life. PolyHeme can stand up to one year. PolyHeme also can be universally distributed, while blood must only go to matching blood types.

"PolyHeme, so far, has been shown to be very, very safe," Robinson said. "What we don't know yet, without doing these studies, is: 'Is it beneficial?'"

The local portion of the Food and Drug Administration trial is being spearheaded by researchers with KU Medical Center.

Organizers of the PolyHeme trial say that because it is aimed at trauma patients in the worst emergencies, informed consent isn't possible. The trial has received a special waiver, allowing Northfield and local organizers to conduct a public-information campaign and offer opt-out bracelets for potential patients to wear.

To date, Douglas County residents have asked for 31 out of 75 bracelets distributed. During an emergency, a patient or the patient's family also can request to opt out.

Robinson said PolyHeme use wouldn't be limited to poor and minority residents, as alleged in California.

"We don't treat people based on where they live or what their ability to pay is," he said. "We treat people based on what their medical needs are."

Michael Moncure, a KU doctor serving as the principal local investigator, said the trial has had to go through a rigorous process with the FDA. If it's found that patients who receive the substitute do worse than they would with the standard treatment, he said, the study would be stopped.

A spokesperson for Northfield Laboratories did not return a phone call Monday. A meeting between Northfield officials and representatives of the San Diego Reader is set for today, Spirra said.

Comments

KsTwister 9 years, 7 months ago

LJW should ask how many Douglas County residents have ordered bracelets from elsewhere.The number is much higher. I know I have family that has 26 of them. And may I add that it is nice that once you put it on you cannot take it off again.clever People have a right not be the quinea pig. Of course, testing it on dying people to some-that's different. I don't believe there is just another 5 people who have the bracelet here.I smell a rat....test it on him.

badger 9 years, 7 months ago

KSTwister-

They did. They tested it on years' worth of rats. And probably pigs, and bunnies, and monkeys (though monkeys are pretty expensive these days).

Human efficacy testing, as the final stage of any product development, is always a little dicey ethically if you can't do a closed study. You have to be very careful - and let me say that being allowed to conduct this sort of open opt-out study is really really rare and those studies are carefully monitored.

Part of what they've been told to do, according to the article here, is conduct a public education campaign. I've only seen one article that looked like they were trying to educate the public, but perhaps there are also TV commercials or something. They do need, very much, to be forthcoming with information to answer people's questions.

To those who insist that there must be another way to do this testing, I ask what that might be? They've tested for safety, for compatibility, for whether or not the substance itself is harmful. The only way to test its usefulness in a trauma situation is to put it into trauma situations, period. Since creating trauma situations involving humans is manifestly unethical, and since seconds matter too much in those situations to explain and get a signed waiver - not to mention that there's the argument of whether or not someone in intense pain, losing incredible amounts of blood, and at best edging into unconsciousness is actually fit to consent to something like that - how do you propose that this testing be conducted? Don't say computer modeling. To get this far, they've already done the modeling, the animal studies, the safety testing (probably more than was done on Celebrex...), all the options that aren't 'Find people in trauma situations and give it to them to see if it improves their chances of getting back to the hospital alive.'

badger 9 years, 7 months ago

Well, if I lived in Lawrence and were inclined to deliberately subject myself to a trauma situation in the name of science, I would. In the meantime, perhaps I'll get hit by a car while visiting someday, in which case I'll be glad of any little edge I can get.

I'm not saying everyone has to do it. I'm saying that the indignation and hysteria I've seen overall in conversations about this, as well as the vague conspiracy theorist theme, that they're experimenting on dying people because no one cares about dying people, or that they targeted minorities, or that the company is 'hiding stuff', is irrational and unrealistic.

  1. They aren't experimenting on dying people because no one cares about dying people. They're experimenting on people who have been exposed to a serious trauma situation because those people are the test subjects for the field use of the product. They represent the end user, the person to whom the efficacy of this stuff will be a life and death matter. This stuff isn't going to be used when you're in surgery and you need blood. It's designed for field trauma situations, and this is the way they have designed to test it in field trauma situations.

  2. They 'target' certain types of injuries, not certain types of people. Some of those injuries are gunshot wounds and serious knife wounds, which you're more likely to find in low-income areas, and low-income areas in much of the country will be heavily populated with minorities. Serious car accidents are another target, but those won't be skewed strongly enough towards wealthier areas to make up for the fact that the use will be heavy in low income and minority areas - not through any direction of the testing, but through the simple demographics of trauma injury. Show me statistics that say that the percentage of PolyHeme test cases in these populations was not in line with the percentage of serious trauma injuries needing fluid replacement in these areas, and I'll take back this entire paragraph.

  3. There's an opt-out option. If you're really so burned, opt out and make sure everyone you know is aware of that option. If people really objected that strongly, and a large part of the population opted out, they'd take their study elsewhere.

I just don't see the need for getting huffy. I also notice that you didn't offer any suggestions, just more defensiveness.

Really, I'd love to hear from someone who's all bent out of shape about it, how should they collect data on the effectiveness of this product in human trauma situations? Or should they just approve and release the product for use without the data?

Chrissy Neibarger 9 years, 7 months ago

I know there are 4 in my family that have the bracelets, although none of us are actually wearing them.. how cumbersome did they have to make them? We all have them on our keychains and hopfully they will see them if it ever comes to that. Anyone know how long this study is supposed to last, do we have to wear these braclets for the rest of our lives?

italianprincess 9 years, 7 months ago

My boys can have my blood.....all three of us have the same type.

nonsmoker 9 years, 7 months ago

No amount of advertising in Lawrence is going to tell an out of state visitor (possibly just driving through town) that they need to have a bracelet to have nonexperimental trauma care in Lawrence. Are they planning on experimenting on just locals or does everyone who might be driving through Lawrence need to get a bracelet, I wonder?

italianprincess 9 years, 7 months ago

Bob,

I have to agree with you on this one. I surely wouldn't want my boys' to go without emerg care if they could. If this blood is tested and found to be okay then I wouldn't mind it being given to my boys' if needed for an emerg only. Then they can draw mine since we all have the same blood type.

You know what.........thank God that drunk guy didn't kill my son. Not only would he have to deal with the court system he would have to deal with me. Got a letter the other day......the city is pressing criminal charges against this guy. The letter says I don't have to be there for his first day in court......hmmmmmmm, okay sure. I will be there and then again for his sentencing. I want this guy to go away for awhile and grow up. If the judge decides to be to nice, then you will be reading about in the paper.

italianprincess 9 years, 7 months ago

Bob,

And I will be his worst nightmare now and for the rest of his life.

Charles L Bloss Jr 9 years, 7 months ago

If I needed a replacement for blood in an emergency I would rather try this instead of saline. This product is designed to carry oxygen which in that sort of injury is crucial. I was a polio pioneer in 1954, trying the first vaccine, and I'm still here. Someone has to take a chance to help others, or no medical breakthroughs would ever happen. Of course, I hope not to be a trauma victim in the first place. Thank you, Lynn

Hong_Kong_Phooey 9 years, 7 months ago

I'm sure, as I'm lying on the floor bleeding out, my first question for the EMT is going to be "Is that REAL blood??"

IP: I'm sure you mean that you will only be his worst nightmare until he serves whatever punishment he gets. After that his debt to society is paid. Too often people try and keep making those convicted of a crime keep on paying long after they have served their sentences.

italianprincess 9 years, 7 months ago

Of course Hong Kong...........I'm just hoping for a huge sentence and alot of time served. If the judge is to nice I will as a mom cause a problem. I have the right to do so to make sure this guy doesn't have the chance to what he did to anyone else.

Godot 9 years, 7 months ago

My kids don't live near; I have a rare blood type. I'll take the risk of the new stuff. Better than nothing.

KsTwister 9 years, 7 months ago

Then I hope you won't find you made a mistake if you do take it and its has a flaw that manifests itself years later.

Linda Endicott 9 years, 7 months ago

Okay, I've read the article listed, and several others. I find a few things that are disturbing to me.

One, the subjects on which PolyHeme will be used are chosen pretty much by "the toss of a coin"...this product is not merely being used as a substitute until the patient arrives at the hospital, as someone stated on another thread. After arriving at the hospital, the patients who received PolyHeme in the ambulance will continue to receive it for the next 12 hours in the hospital.

Effectiveness and safety will be measured by survival rates of patients. Wow. That sounds pretty cold to me.

I checked out Northfield's own website. Though they state that this product is made using chemicals, they do not state which ones or how they're used. That apparently is a trade secret and they won't reveal it.

Another disturbing fact is that children under the age of 18 and pregnant women are automatically opted out of the study. If they think it's so damn safe, why are they excluding these groups?

Prior to the study, it was discussed that instead of having people opt out of the study, instead they could have people who chose to be guinea pigs wear bracelets stating that they agreed to it. This idea was trashed, as they didn't think they could find enough people who would agree.

Is there anyone else who thinks this stuff isn't nearly as safe as they claim it is?

lori 9 years, 7 months ago

Not that anyone is going to read this, since it's old news, but...

Preg women and children are never part of a generalized study. That's just standard. Even if the medication studied is specifically for preg women or children, it has to be studied in the general adult non-pregnant population first.

Also, it is hemoglobin that has been altered. It is still a blood product, from what the fact sheet from the company states.

Just because you have the same blood type doesn't mean you can exchange blood. Different people with the same blood type can have different antigens, and this could be catastrophic if not controlled for.

friendtoall 9 years, 7 months ago

Most of these posts call to mind the saying that "a little bit of knowledge is dangerous." Did anyone here bother to look up the results of previous polyheme trials? Did anyone wonder why the FDA would allow a non-consent trial for polyheme knowing the potential fallout if things go wrong? Does anyone here think that the physicans at thirty level one trauma centers would decide to use a product on hundreds of patients if they weren't convinced that not only was it safe, but that it provided a distinct survival advantage to the patient? Has anyone looked at the results of the last polyheme trauma trial where patients who recieved polyheme had twice the survival rate in severe trauma compared to the control group? No I didn't think that you had.

Go back to reading People magazine and watching Friends reruns. When you have done your homework, and have an INFORMED opinion, come back and post it.

Linda Endicott 9 years, 7 months ago

There have been many, many products over the years that they thought were perfectly safe and it turned out they weren't. Unfortunately, it may not become apparent for decades.

Lead based paint and asbestos come to mind...

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