From Feb - Artificial Blood Tested Without Patient Consent

[Guest guest]

http://www.cnn.com/2004/HEALTH/02/20/blood.substitute.ap/index.html

Artificial blood tested on patients without consent

Friday, February 20, 2004 Posted: 9:27 AM EST (1427 GMT)

PolyHeme blood substitute is made by extracting hemoglobin from red

blood cells and can be used in patients with any blood type,

according to its maker.

CHICAGO, Illinois (AP) -- Paramedics are testing an experimental

blood substitute on severely injured patients without their consent

in an unusual study under way or proposed at 20 hospitals around the

country.

The study was launched last month in Denver and follows similar

research that was halted in 1998, when more than 20 patients died

after getting a different experimental blood substitute.

Supporters say the current product, PolyHeme, made by Northfield

Laboratories of ton, Illinois, is safer and could save many of

the nearly 100,000 people who die of bleeding injuries each year

nationwide.

" It could revolutionize how we take care of resuscitation in the

United States and across the world, " said lead investigator Dr.

Ernest , chief of trauma surgery at Denver Health Medical

Center.

The research is part of a race to find what doctors call the holy

grail of emergency medicine: a product that works like human blood to

save victims of car crashes, shootings or other trauma but could be

carried in ambulances and given to people of any blood type.

Patients will be randomly selected to receive PolyHeme intravenously

or standard saline solution at the scene or en route to the hospital.

Because severely bleeding trauma patients often are unconscious or in

shock, they are unable to give the consent required for experimental

treatment. As a result, the researchers in this case are being

allowed to bypass the consent rules under a 1996 federal exemption

that applies to emergency, potentially lifesaving research.

The exemption requires the research to be publicized beforehand in

communities where the study will be conducted, both to let people opt

out if they are ever injured and to give the community a chance to

express any objections. In effect, the community briefings are used

to obtain consent.

The Food and Drug Administration has approved about 15 such no-

consent studies since the exemption was added.

Ethics debated

University of Pennsylvania bioethicist Dr. Karlawish said there

is nothing unethical about the concept.

Some patients' rights advocates disagreed, especially considering the

deaths in the earlier study of emergency room patients given a Baxter

Healthcare blood substitute.

The study " is another one along that slippery slope that's

essentially demolishing your individual right not to become

experimental subjects unless we give prior, voluntary, informed,

comprehending consent, " said Vera Sharav, president of the New York-

based Alliance for Human Research Protection, a group concerned with

the safety of the millions of Americans who participate in medical

research each year.

Baxter has said there is no proof its product caused the deaths; a

spokeswoman said it has abandoned research into a blood substitute.

The centers where the PolyHeme study is under way or proposed include

the University of Texas Medical School in Houston; Loyola University

Medical Center in Maywood, Illinois; Mayo Clinic in Rochester,

Minnesota; and Regional Medical Center in Memphis, Tennessee.

Northfield Laboratories would not disclose the names of the other

participating hospitals.

At community meetings, PolyHeme researchers offer light-blue plastic

bracelets reading: " I Decline the Northfield PolyHeme Study. " Only a

few people have requested the bracelets, said.

Community input

At a community health fair this week in Berwyn, Illinois, 57

residents listened to Loyola's pitch. Only one objected to the study

on a response form.

Berwyn resident Mars said she would be a willing subject.

" At my age, I couldn't care less, " said Mars, 79. " They might save a

lot of lives. "

Dr. Gamelli, chief of Loyola's burn center, will lead the

study at Loyola if the hospital institutional review board approves

it. " It's not really that much of an ethical or moral dilemma, "

Gamelli said.

At an accident scene, the rescue squad " doesn't ask you if you want

to be removed from your car " or given cardiopulmonary resuscitation,

Gamelli said. " We kind of have a social contract to do the right

thing already " without seeking consent.

Earlier PolyHeme studies showed it was safe in hospitalized patients

and could be used to temporarily replace a patient's entire blood,

Gamelli said.

In severely bleeding patients, replacing blood volume quickly is

critical to survival.

Ambulances do not carry human blood, which has a short shelf life.

Instead, patients get an intravenous saline solution to temporarily

build up fluid volume and restore blood pressure. But unlike blood,

the fluid does not contain tissue-nourishing oxygen, so patients risk

organ damage.

PolyHeme lasts longer than blood. Also, it is made by extracting

oxygen-carrying hemoglobin from human red blood cells and can be used

in patients with any blood type.

The blood substitute safely dissipates in the body after about 24

hours, the company said.

--------------------------------------------------------

Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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[Guest guest]

<<Supporters say the current product, PolyHeme, made by Northfield

Laboratories of ton, Illinois, is safer and could save many of

the nearly 100,000 people who die of bleeding injuries each year

nationwide. >>

I wonder if Northfield is connected to Eli-Lilly, they are neighbors.

Ohio

)0(~~~)0(~~~)0(

Mom to Brittany, born 8/31/93, dx'd-IDDM 5/28/01; , born 6/28/97;

and Shayna, born 6/1/00.

Vaccine free since 1999! See our site and get more vaccine info at

<http://users.adelphia.net/~tacousino/>

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[Guest guest]

At 06:04 PM 03/26/2004 -0500, you wrote:

><<Supporters say the current product, PolyHeme, made by Northfield

>Laboratories of ton, Illinois, is safer and could save many of

>the nearly 100,000 people who die of bleeding injuries each year

>nationwide. >>

>

>

>I wonder if Northfield is connected to Eli-Lilly, they are neighbors.

>

>

>Ohio

>)0(~~~)0(~~~)0(

See what you can find out if you can .

Sheri

--------------------------------------------------------

Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

$$ Donations to help in the work - accepted by Paypal account

vaccineinfo@... voicemail US 530-740-0561

(go to http://www.paypal.com) or by mail

Vaccines - http://www.nccn.net/~wwithin/vaccine.htm

Vaccine Dangers On-Line course - http://www.nccn.net/~wwithin/vaccineclass.htm

Homeopathy On-Line course - http://www.nccn.net/~wwithin/homeo.htm

ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL

OR LEGAL ADVICE. THE DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

******

" Just look at us. Everything is backwards; everything is upside down.

Doctors destroy health, lawyers destroy justice, universities destroy

knowledge, governments destroy freedom, the major media destroy information

and religions destroy spirituality " .... Ellner

[Guest guest]

<<See what you can find out if you can .>>

LOL Well, I started out, found the home page for both companies. But

not seeing any obvious connections, how does one find out if a company

is connected to another. Northfield does have it's own stock symbol if

that means anything. (I'm not a financial minded person.)

The sites are http://www.lilly.com <http://www.lilly.com/> and

http://www.northfieldlabs.com <http://www.northfieldlabs.com/> .

Apparently this PolyHeme is the only thing that Northfield does - it's

the only product listed on their site that I've seen so far.

Ohio

)0(~~~)0(~~~)0(

Mom to Brittany, born 8/31/93, dx'd-IDDM 5/28/01; , born 6/28/97;

and Shayna, born 6/1/00.

Vaccine free since 1999! See our site and get more vaccine info at

<http://users.adelphia.net/~tacousino/>

http://users.adelphia.net/~tacousino/