Post by Merkuri on Apr 6, 2004 12:28:47 GMT -5
[From Wired News: www.wired.com/news/medtech/0,1286,62955,00.html?tw=wn_tophead_2 ]
Fake Blood, Real Controversy
By Randy Dotinga
02:00 AM Apr. 06, 2004 PT
Thanks to an unusual loophole in the strict rules of medical ethics, hundreds of trauma patients in California, Texas and a few other states will be taking a gamble when ambulances come to scoop them up after accidents or acts of violence.
Without waiting to get consent, paramedics will inject a fake blood product into half of the eligible patients chosen to take part in a new study. The other half will get a routine treatment of transfusion with saline solution until they reach the hospital.
For now, the artificial blood, known as PolyHeme, isn't approved for general use. But it will still slip into the veins and arteries of unconscious patients who won't be able to say no.
"Emergency research in general creates a special set of circumstances," said Kelly Fryer-Edwards, a University of Washington medical ethicist whose colleagues across the country are divided over the wisdom of the blood study. "In a way, all of our usual approaches to research ethics -- to protecting human subjects, to trying to get informed consent -- just go out the window."
At stake is a product that could revolutionize emergency medical treatment and surgery.
It's no secret that donated blood is often in short supply. Blood banks, often entangled in competition and internal politics, frequently launch desperate appeals for donations. And even when fresh blood is available, paramedics and surgeons can't immediately pump it into a hemorrhaging patient.
First, they must check the patient's blood type, a process that takes time, said Dr. Ernest Moore, chief of trauma surgery at Denver Health Medical Center, which has been testing PolyHeme for 11 years. "Most hospitals claim they can do it in 20 minutes, but practically, it's a half hour, and at many institutions it's 40 minutes to an hour."
The "universal donor" blood, type O-negative, can be transfused into people of all blood types. However, only 7 percent of people have that blood type. "There's always a shortage of (O-negative) in any type of hospital that does a lot of acute care," Moore said. "It would be impossible to supply that throughout ambulances."
When patients are bleeding heavily, paramedics try to replace missing blood with infusions of saline solution (salt water). But saline solution -- the same stuff people use to rinse their contact lenses -- doesn't carry oxygen like blood and instead just acts as a space filler.
Enter modern artificial blood products, which have been under development since the 1970s. Researchers are trying to create products that transport oxygen like blood does, are compatible with all people, can be stored for long periods (donated blood expires after 42 days) and won't transmit diseases, said Dr. Stephen A. Gould, chairman and CEO of Evanston, Illinois-based Northfield Laboratories, which manufactures PolyHeme.
According to Gould, only two artificial blood products -- PolyHeme and Hemopure, by Massachusetts-based Biopure -- are in the final phases of research. Hemopure, used in surgeries, is made from cow blood, while PolyHeme is derived from hemoglobin, a protein found in red blood cells. Hemoglobin lasts much longer than blood and is a one-size-fits-all solution because it doesn't include the antigens -- the soldiers of the immune system -- that arm red blood cells against foreign blood types.
PolyHeme is also thinner than regular blood, which may make it easier to use in hemorrhaging patients, Gould said, raising the possibility that it may actually be better than blood in some situations. "That's a judgment call."
There's another benefit, too, one that has gotten little attention. While the Jehovah's Witness church discourages transfusions due to the biblical stricture against the consumption of blood, it has given its 1 million American members leeway to accept products that are not derived from the major components of blood. (Other religions, including the Christian Science church, frown on medicine in general and will not be affected by the availability of artificial blood.)
While surgeons have tested PolyHeme on at least one Jehovah's Witness, they have done so after getting permission. The new study, which began earlier this year, doesn't require consent from patients.
Northfield Laboratories hopes to enlist 20 hospitals in the one-year study, which will enroll 720 patients. While the company hasn't publicly listed the hospitals that are taking part or considering participation, news reports have revealed that they include the Denver Health Medical Center; University of California at San Diego Medical Center; 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.
Hemorrhaging patients -- including victims of car accidents and gunshot wounds -- will be eligible for the study, with the exceptions of pregnant women and those with serious head wounds. The patients will be randomly assigned to receive saline solution or PolyHeme.
Each of the hospitals will have to hold community meetings to educate residents about the study. In Denver, health officials allow those who don't want to take part to ask for bracelets that would let them opt out. The Associated Press reported that only one person out of 57 objected to the study at a community meeting in Illinois near Loyola University Medical Center.
The hospitals are complying with a federal loophole created by Congress in 1996. It allows the lifting of rules about informed consent when research involves emergency medical treatment.
In 1998, a company called Baxter Healthcare launched the first major study of a blood substitute using the loophole. According to news reports, nearly half of 52 patients died and the study was halted.
George Annas, a medical ethicist at Boston University, criticized that study and thinks the people behind PolyHeme are making the same ethical errors. It's wrong to "treat human beings like animals, like laboratory animals," he said. "People have a right not to be research subjects."
The right to opt out by wearing a bracelet isn't enough, he added, although he declined to offer a better system. "It should be up to the study sponsor to figure out how to do the study ethically, not the people who criticize the study."
A prominent advocate of patients' rights says people should have to wear a bracelet to get into the PolyHeme study, not get out of it. There's simply no proof that the artificial blood is safe, said Vera Hassner Sharav, president and founder of the New York-based Alliance for Human Research Protection. "Therefore, we shouldn't be testing it in people who cannot say no."
Fryer-Edwards, the medical ethicist at the University of Washington, looks at things a bit differently. It may be very difficult to find citizens willing to volunteer for a study of trauma patients, she said, because people don't like to think about the prospect of an accident.
By enrolling people automatically, she said, "you're putting the responsibility on the person who wants to opt out, and that's an extra obligation you've created for them. But you have respected their autonomy by giving them that choice."
Fake Blood, Real Controversy
By Randy Dotinga
02:00 AM Apr. 06, 2004 PT
Thanks to an unusual loophole in the strict rules of medical ethics, hundreds of trauma patients in California, Texas and a few other states will be taking a gamble when ambulances come to scoop them up after accidents or acts of violence.
Without waiting to get consent, paramedics will inject a fake blood product into half of the eligible patients chosen to take part in a new study. The other half will get a routine treatment of transfusion with saline solution until they reach the hospital.
For now, the artificial blood, known as PolyHeme, isn't approved for general use. But it will still slip into the veins and arteries of unconscious patients who won't be able to say no.
"Emergency research in general creates a special set of circumstances," said Kelly Fryer-Edwards, a University of Washington medical ethicist whose colleagues across the country are divided over the wisdom of the blood study. "In a way, all of our usual approaches to research ethics -- to protecting human subjects, to trying to get informed consent -- just go out the window."
At stake is a product that could revolutionize emergency medical treatment and surgery.
It's no secret that donated blood is often in short supply. Blood banks, often entangled in competition and internal politics, frequently launch desperate appeals for donations. And even when fresh blood is available, paramedics and surgeons can't immediately pump it into a hemorrhaging patient.
First, they must check the patient's blood type, a process that takes time, said Dr. Ernest Moore, chief of trauma surgery at Denver Health Medical Center, which has been testing PolyHeme for 11 years. "Most hospitals claim they can do it in 20 minutes, but practically, it's a half hour, and at many institutions it's 40 minutes to an hour."
The "universal donor" blood, type O-negative, can be transfused into people of all blood types. However, only 7 percent of people have that blood type. "There's always a shortage of (O-negative) in any type of hospital that does a lot of acute care," Moore said. "It would be impossible to supply that throughout ambulances."
When patients are bleeding heavily, paramedics try to replace missing blood with infusions of saline solution (salt water). But saline solution -- the same stuff people use to rinse their contact lenses -- doesn't carry oxygen like blood and instead just acts as a space filler.
Enter modern artificial blood products, which have been under development since the 1970s. Researchers are trying to create products that transport oxygen like blood does, are compatible with all people, can be stored for long periods (donated blood expires after 42 days) and won't transmit diseases, said Dr. Stephen A. Gould, chairman and CEO of Evanston, Illinois-based Northfield Laboratories, which manufactures PolyHeme.
According to Gould, only two artificial blood products -- PolyHeme and Hemopure, by Massachusetts-based Biopure -- are in the final phases of research. Hemopure, used in surgeries, is made from cow blood, while PolyHeme is derived from hemoglobin, a protein found in red blood cells. Hemoglobin lasts much longer than blood and is a one-size-fits-all solution because it doesn't include the antigens -- the soldiers of the immune system -- that arm red blood cells against foreign blood types.
PolyHeme is also thinner than regular blood, which may make it easier to use in hemorrhaging patients, Gould said, raising the possibility that it may actually be better than blood in some situations. "That's a judgment call."
There's another benefit, too, one that has gotten little attention. While the Jehovah's Witness church discourages transfusions due to the biblical stricture against the consumption of blood, it has given its 1 million American members leeway to accept products that are not derived from the major components of blood. (Other religions, including the Christian Science church, frown on medicine in general and will not be affected by the availability of artificial blood.)
While surgeons have tested PolyHeme on at least one Jehovah's Witness, they have done so after getting permission. The new study, which began earlier this year, doesn't require consent from patients.
Northfield Laboratories hopes to enlist 20 hospitals in the one-year study, which will enroll 720 patients. While the company hasn't publicly listed the hospitals that are taking part or considering participation, news reports have revealed that they include the Denver Health Medical Center; University of California at San Diego Medical Center; 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.
Hemorrhaging patients -- including victims of car accidents and gunshot wounds -- will be eligible for the study, with the exceptions of pregnant women and those with serious head wounds. The patients will be randomly assigned to receive saline solution or PolyHeme.
Each of the hospitals will have to hold community meetings to educate residents about the study. In Denver, health officials allow those who don't want to take part to ask for bracelets that would let them opt out. The Associated Press reported that only one person out of 57 objected to the study at a community meeting in Illinois near Loyola University Medical Center.
The hospitals are complying with a federal loophole created by Congress in 1996. It allows the lifting of rules about informed consent when research involves emergency medical treatment.
In 1998, a company called Baxter Healthcare launched the first major study of a blood substitute using the loophole. According to news reports, nearly half of 52 patients died and the study was halted.
George Annas, a medical ethicist at Boston University, criticized that study and thinks the people behind PolyHeme are making the same ethical errors. It's wrong to "treat human beings like animals, like laboratory animals," he said. "People have a right not to be research subjects."
The right to opt out by wearing a bracelet isn't enough, he added, although he declined to offer a better system. "It should be up to the study sponsor to figure out how to do the study ethically, not the people who criticize the study."
A prominent advocate of patients' rights says people should have to wear a bracelet to get into the PolyHeme study, not get out of it. There's simply no proof that the artificial blood is safe, said Vera Hassner Sharav, president and founder of the New York-based Alliance for Human Research Protection. "Therefore, we shouldn't be testing it in people who cannot say no."
Fryer-Edwards, the medical ethicist at the University of Washington, looks at things a bit differently. It may be very difficult to find citizens willing to volunteer for a study of trauma patients, she said, because people don't like to think about the prospect of an accident.
By enrolling people automatically, she said, "you're putting the responsibility on the person who wants to opt out, and that's an extra obligation you've created for them. But you have respected their autonomy by giving them that choice."
