Monday, November 28, 2005

New Blood.... (Updated & Bumped)

This is a reminder to all Houston residents. You may find yourself the subject of a medical experiment without your consent. Sounds bad doesn't it? Well, maybe not. You see, there is a company that is conducting a Phase III trial of a synthetic blood substitute here in cooperation with over 18 sites around the country including Hermann Hospital's Life Flight. If Life Flight responds to an emergency where the victim has suffered massive blood loss, and has no contraindications for it's use (pregnant or may be so, massive head trauma, or any other injury that is not likely to allow the patient to survive), that patient may, by random lot, be given a product called PolyHeme. This product, made by Northfield Labs, is made from expired human blood. The red cells are separated out, chemically broken open and the hemoglobin is separated from the rest of the cellular material. The hemoglobin is then polymerized. This is a crucial step. Hemoglobin is a very small molecule, so small that it can leak through capillary walls and damage organs. But by polymerizing it, Northfield has found a way to link multiple hemoglobin "tetramers" into long chains which will not leak through capillary walls.

Conventional therapy for blood loss at an accident scene is to supply saline to attempt to dilute the remaining blood in the system. Saline can only do so much however, it cannot carry oxygen itself, if the remaining blood volume is too low, the diluted blood cannot carry enough oxygen to keep the brain and vital organs alive. In Phase I and II trials of PolyHeme some patients have had over twice thier blood volume replaced with PolyHeme with no adverse effects. This product has a shelf life of a full year, this after already expiring as whole blood. This product has no blood antigens in it, so it is universal and requires no typing. This product has been approved by the Jehova's Witnesses as suitable for use. As I type, over 250 patients have recieved this product at the scene of an accident and the goal of the trial is 750 patients. This trial is possble because the FDA has a stipulation that if sufficient local notification is made, and the patient is in serious risk of dying without the experimental treatment, the patient can be enrolled without providing informed consent.

Full disclosure: I own stock (admittedly less than I'd like to own, but my investment money is limited.) in this company. I do so because I believe this is a revolutionary product that can save thousands of lives a year. If you'd like to learn more you can go to Northfield Labs Website

UPDATE: 11/28/05

Northfield labs has announced the results of the fourth (and I believe final) interim review of the Phase III study with positive results. The independent review committee looked at the outcomes of the first 500 patients and concluded that no modification to the study needs to be made and the study can continue without interruption. A new day in acute trauma care steadily marches closer.

11 Comments:

Blogger Shreela said...

Rorschack,

Have you, or anyone else in your family, been transfused with this synthetic blood?

Sherri

June 14, 2005 10:50 AM  
Blogger Rorschach said...

Nope, Thankfully nobody I know has had the misfortune of needing a transfusion of any type. What I find most interesting about this product is the fact it can be administered AT THE SCENE. Since typing is not an issue, there is no worry about blood type matching. I'm still researching it myself but I have read that the DOD supplied a large chunk of research money through DARPA for the early development. Makes sense. I have surmised, but I'm not sure, that the product can be freeze dried and rehydrated at the scene. I could see where the DOD would LOVE to put this stuff in an army medic's bag. Or even better in every soldiers pack. Given the small single use water filters that are available, I can envision a medic scooping up a bucket of muddy swamp water, pumping it through one of these filters, using this filtered water to rehydrate the blood substitute and saving a fellow soldiers life in the middle of some battlefield somewhere. Gives the whole "golden hour" concept a new twist.

The reason why I posted about it is that the study is half finished and I haven't seen a peep about it anywhere except the Chronicle and then only right before the study started back on February 12, 2004. It seems reasonable that people might want to know about this. And I'm sure not everybody saw the original article over a year ago.

June 14, 2005 4:05 PM  
Blogger Shreela said...

OMGosh! Swamp water to synthetic freeze-dried blood! I suppose if my life depended on it, AND it had been thoroughly tested, I'd get over it, but ewww! LOL But I can see why DARPA would be interested in it. I've read some of their other interests that were much creepier from defense newsfeeds.

If they find no future complications from their tests, I think synthetic blood would be good for ambulances since fresh blood (unfrozen) only lasts for two hours, and carries serious risks from mis-typing. I don't recall any of our patients that recieved blood expanders having serious complications from it (one brand did give bad diarrhea).

I read something about synthetic blood being tested in another city, maybe about 6-12 months ago. But not much since, and I subscribe to quite a few medical/science newfeeds (but when I get behind online, I mark many feeds as read even though I didn't glance through them, so I could have missed a more recent article).

June 17, 2005 2:02 AM  
Blogger Rorschach said...

well, I can see where it might gross you out, but there are reverse osmosis filters that can filter out stuff as small as viruses, (prions? dunno) so risk of infection should be non-existant. and if its a question of keeping the guy alive or not, hey, they can always administer antibiotics back at the batallion aid station.

June 19, 2005 7:52 AM  
Blogger Rorschach said...

Just had a look over the Northfield site, there have been over 400 patients enrolled as of the first week in July. Northfield expects the number to be at or around 600 by year end. They expect to issue a progress report based on the last interim look before the study ends before the end of the year. The study is expected to end in the first quarter of 2006 if not sooner at current enrollment rates.

October 03, 2005 2:00 PM  
Blogger Pigilito said...

That is a product with tremedous potential. Aside from being used by ambulance crews, it will be helpful in the ER.

In Europe (and I suspect the US) most volume expanders (which seems to be the main use for the product) are either colliods or crystalliods rather than saline solutions. Do you hace any idea of how it is expected to compare in cost to other volume expanders?

Too high a cost may limit it to only the worst sorts of trauma.

In any case, please keep posting on this topic. My wife is an anesthesiologist (in much of Europe they staff ambulances) and had never heard of the trials. She is quite interested.

Also, JWs are more frequently showing up in the ORs here in Bern. Such a product could help eliminate blood loss risks.

December 02, 2005 4:51 AM  
Blogger Rorschach said...

I do not expect cost to be a huge driver in this products acceptance. I'm sure there will be some volunteer ambulance services that cannot afford to put in thier ambulances, but those operated by the county/city probably will. Northfield has not made public it's marketing plans so nobody knows what it is going to cost per unit. I would expect few people will complain about the bill if it keeps them alive.

December 02, 2005 9:06 AM  
Blogger drugseekersbeware said...

Hey Guys. I just found your tread after being linked to it on the yahoo message boards. It is the message board for people with investments in Northfield Labs, the company that is making polyheme, the blood substitue that you are discussing. I guess I don't have to disclose that I am an investor in the company.

In addition to being an investor, I am a physician assistant who has worked emergency medicine for nine years, and I know that there is a profound need for a product like polyheme.

Northfield has spoken about the pricing of poyheme. They figure it will be around a thousand dollars a unit. Before everyone passes out at the keyboard, the average cost of a unt of transfused "normal" blood is between $500 and $750 a unit when you factor in collection expenses, storage, type and cross matching, documentation for ensuring that the right person gets the correct blood type, etc, etc. Then you have to consider the lost revenue when those units of blood expire after only 42 days and have to be thrown away. Polyheme will last about 15 months so the amount that become expired and have to be discarded should be very small in number.

The other thing to consider when considering cost is that patients who are given polyheme at the scene of the accident and in the ambulance should be in better shape when they reach the hospital compared to those who have to wait until they get to the hospital to recieve blood. I work in a rural area in Kentucky and it is not uncommon to have a transport time of a half an hour to our emergency room. Polyheme will be most valuble out here in the rural areas where the tranport times are longer.

Because patients given polyheme in the ambulance will be oxygenating their brain, kidneys and liver during the transport, the amount of organ damage cause by the loss of blood and therefore oxygen deprivation to these organs, should be dramatically decreased. what does that mean in the big picture? Polyheme patients are likely to spend less time in the hospital, spend less time in the ICU, have less complications like permanent organ damage, be less likely to develop mulitple organ failure, and should have less lifelong disabilities. Beyond the human tragedy, the twenty year old who suffers brain damage from lack of oxygen will spend the next 15 years in a long term care facility and will cost the insurance cpmpany "the system" hundreds of thousands of dollars, to take care of the results of an injury that could have been prevented with four thousand dollars of polyheme.

When you look at it from that standpoint, and that is how the bean counters at the insurance companies will look at it, polyheme would actually save the "system' many many times more dollars that it costs. We live in a society that accepts chemotherapies for cancers that cost $12,000 a dose and may prolong the life of a patient by four to six months. Polyheme will cost about a thousand dollars a unit and will save a life or prevent a devastating brain injury and other organ damage. I think it will be seen as bargain. If it were someone you or I loved bleeding to death, would we think twice about the cost?

Thanks for letting me post on your blog Rorscharch, it is pretty cool. I have book marked your blog, if anyone has any comments or thinks I'm crazy, I would love to hear for you. Thanks again.

December 10, 2005 11:16 AM  
Blogger Rorschach said...

DSB, thanks for stopping by! I was unaware that Northfield had publically disclosed any marketing plans. Your price of a grand per unit does at first blush stagger you a bit, but your reasoning for it saving money seems sound. That said, your argument that insurance companies will look far enough ahead to see that it will save money in the long run may or may not be valid.

Medical insurance companies tend to think in terms of quarters, or a year at most. They don't look at 5, 10, or 20 year time spans. The reason is that most people who are severly injured cannot work and many don't have long term disability insurance and therefore they blow through thier savings quickly and cannot keep up the insurance payments and thier insurance is dropped. They end up on the public dole for long term care. For years, medicare would pay for surgery, but wouldn't pay for care that would prevent surgery. This is of course a result of political choices made by people who have no grasp of medicine or the insurance industry. (these are the same sorts of decisions that have left us with only two vendors for injectable flu vaccine and a third nasal vaccine that nobody including private insurance will pay for ) These will be the same sort of people who make similar decisions about outfitting private, volunteer, city and county ambulances with polyheme. I'm not particularly encouraged by that thought.

Just take a look at the quality of care you get in any British or Canadian hospital and you'll see what I mean. If an American hospital treated thier patients that way they'd be sued into oblivion by the widows and widowers. But there everyone just shrugs, lights up another cigarette, and says, well, my doctors visits are free, why should I worry about cancer? Without realizing that in the states, if they get cancer, they might have a decent chance at surviving whereas in Canada, they are basically pumped full of moriphine and allowed to die of it because the cost of all but the most inexpensive chemo and radiation is too high. You get the care you pay for.

December 10, 2005 9:52 PM  
Blogger drugseekersbeware said...

Hey Rorschach,

If you go to the American College of Surgeons web site they have a full collection of trauma statistics for the U.S. A lot of trauma patients have no insurance at all and the hospital eats the costs. The hospitials will likely realize that one less day in the ICU pays for the polyheme if patient outcomes are better.

For other trauma, medicare/medicaid and private auto insurances are the lions share. In my E.R., motor vehicle accidents (MVA) are far and away the cause of the most significant trauma. Most auto policies will have a lifetime benefit cap of a million or so dollars. They will pay out for acute and long term care up to that limit. After that, people are on their own. How the private insurers will respond to polyheme is still up in the air, but my guess is that the bean counters will see after polyheme is out there for a while that it is a money saving proposition. Much like my private medical insurance that just paid 100% of my childrens flu shot fees last month. They didn't do that out of the kindness of their hearts, but because bean counters figure that vaccinating will save the insurer in the long run with decreased doctor visits etc, etc.

The government medicare/medicaid reimbursement is a mystery to me. I know that for medical conditions like pneumonia, the government will pay the hospital X amount of dollars for treating a patient with pneumonia no matter what the actual care provided costs. If the patient deteriorates and ends up on a ventilator or in the ICU, the hospital will end up eating many thousands of dollars on that patient. I'm not sure if they do the same with trauma patients or not. Do you know how that works?

I think the other thing that will drive polyheme to be stocked on ambulances in this country, whether the insurers reimburse 100% or 50%, is that we live in a very litiginous society. The first time someone bleeds out two blocks from the E.R. because the ambulance didn't have polyheme, or worse from an insurers point of view, suffers permanent brain damage from bleeding out on the way to the hospital, the trial lawyers are going to have a field day. One million dollar verdict will pay for a thousand units of polyheme. Hospitals may have no choice but to stock it if it becomes the standard of care, as it will likely become.

That is why hospitals play the shell game. Most emergency rooms are black holes of revenue loss for the hospital, but it is a service they must provide. They make that money back from other patients using the MRI machine and from cardiac caths. Lose money on that medicaid pneumonia, make it back on that bone scan. That is how hospitals play the reimbursement shell game. The only thing keeping our hospital in the black right now are the cardiac caths and open heart surgeries. Much like the University of Kentucky basketball program brings enough revenue into the school's athletic department to subsidize all the other sports on campus.

Time will tell about the insurers. One thing is for sure, polyheme is going to save a lot of lives. Maybe someone we love. We can't wait to get it in our E.R. It will also ensure that more purple hearts are awarded in the hospital to our troops instead of posthomously to their grieving families.

As far as socialized medicine goes you are right on target. If you want something done poorly and at ten times the cost, give it to the federal government to do. One of the docs I work with was an Air Force doc stationed in Spain. He said if you get sick in Spain, it had better be in the first half of the month because towards the end of the month, the public hopitals would run out of medicine, bandages, x-ray film, anesthesia, you name it. It was a nightmare. Americans who grouse if they have to wait more than three minutes in the McDonalds drive through lane will never tolerate being told they need their gall bladder removed and we will be happy to do that for you in nine months, maybe. Oh yeah, and if there is malpractice and you die, you can't sue about it. It's just tough luck for you.

I hope everyone here has a Happy HannaRamaKwanzMas. My nephew and niece aren't allowed to wish anyone a Merry Christmas in their school this year. I thought we had freedom OF religion, not freedon FROM religion in this country. But thats for another blog. Merry Christmas everyone.

December 14, 2005 3:33 PM  
Anonymous Anonymous said...

Is there any other companies making a smiliar product to PolyHeme?

February 28, 2008 3:18 PM  

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