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Is it ethical to test people with experimental treatments without their knowledge or permission? This is what is in question after the FDA approved the testing of an artificial blood substitute, known as PolyHeme.

PolyHeme is a synthetic blood substitute derived from outdated, donated, human blood. Unlike human blood though, PolyHeme does not require blood typing or refrigeration. Another advantage of PolyHeme is that it can carry oxygen to the tissues, unlike blood volume expanders like normal saline. Shelf life is another advantage of the blood substitute. PolyHeme has a shelf life of 12 months, compared to real blood, which has a shelf life of about 42 days.

There are some serious safety issues with PolyHeme though. The first study of PolyHeme was started in 1998 and continued to the year 2000. In this study consent was obtained from patients as is required by law. The patients all had aneurysm surgery of the heart arteries. Ten of the 81 patients receiving the blood substitute died within a week, while none of the 71 patients receiving real blood suffered any heart attacks. This study was not only halted early because of the deaths, but the company who manufactures PolyHeme withheld the fact that people died during the study from the public.

In their most current study, Northfield Laboratories, the maker of PolyHeme, conducted a second study on over 700 patients, without their consent. Some patients receive PolyHeme alone, others received PolyHeme then saline, and the remainder received saline and blood. The study was conducted in various cities throughout the U.S. The FDA approved the testing without consent based on the 1996 Federal regulation CFR 50.24 waiver of informed consent.

The study started with a total of 722 patients. A total of 126 patients were dropped from the study due to what they called “protocol violations”. This includes patients that were too young, or they were excluded for other reasons. Other parameters that excluded patients included patients who have sustained unsurvivable injuries, have severe head injury, are pregnant, have cardiac arrest, or have objected to the study. Out of the remaining 586 patients, 279 were in the group receiving PolyHeme and 307 patients were controls. Incidences of death were higher in each of the groups receiving PolyHeme, compared to each of the control groups. Although, Northfield Laboratories claims that the difference in the number of deaths was not significant.

Northfield Laboratories tried to get FDA approval based on previous studies of trauma patients. The other patients they were comparing had not had blood though. They were trauma patients that had not received blood because of religious beliefs.

In August of 2006, Northfield Laboratories tried to get accelerated approval for PolyHeme. The request was declined by the FDA until further study results come in. I guess they were in a rush since they signed a $6.7 million agreement on June 16th, 2006 to purchase a 106,000 square foot property that they intend to use to manufacture their product. This is really putting the cart before the horse since they don’t have approval for their blood substitute, nor is there any guarantee of approval.

This brings up the question of how far will Northfield Laboratories go to get their blood substitute approved to avoid losing their investment, and the money of their investors? After all, this has been a costly venture. Not only have they spent $6.7 million for the building they intend to manufacture their product in, but they are also paying the hospitals $10,000 for each patient they test the blood substitute on. Tack on to that other research and development costs, manufacturing equipment costs, and other expenses.

Pursuant to CFR 50.24 certain criteria must be met in order for testing to be performed on patients without their consent. For example, section (2) (ii) states “Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects”. So where are these previous animal or preclinical studies? The only study was halted early after a significant increase in deaths in patients receiving PolyHeme. Section (2) (iii) states “Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.” Again, the only clinical study was halted early because of a disproportionate death rate between those receiving PolyHeme, and those that did not. This is hardly reasonable, when standard therapy has been shown to be considerably safer and effective.

The regulation also requires that they try to gain consent prior to, or as soon as possible from a legal representative, such as a relative. From what I have seen, I don’t think this is being done. For instance, if a married couple is in an accident, and only one has sufficient trauma to require blood, are they obtaining consent from the spouse? It does not appear that they are. Instead, saline or PolyHeme were not chosen for the patient until the patient was on the way to the hospital. And according to news reports, the decision was based on sealed envelopes the paramedics opened in route to determine what treatment the patient would be given. Such a practice would prohibit the paramedics from explaining the risks and benefits to the spouse to allow them to make an informed decision, or give time to obtain consent even if the spouse was aware of the risks. If no legal representative can be found, then the company must provide proof of attempts to contact a legal representative.

Section (7) (ii) states “ Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits”.

The first problem with this is that Northfield Laboratories did not disclose the adverse effects of their product found in the 1998 study. In fact they threatened to sue the group that made the fact public claiming that the adverse effects, which included death, were part of their trade secret. I also see a problem with this regulation by the fact that everyone will not be aware of the study since not everyone follows, or has access, to the media. For example, the homeless would not likely know about the study, and therefore there will be no disclosure, as is required, to certain groups. Even though people in these groups may be subjected to the study. The law does allow life saving measures in people unable to give consent, such as unconscious patients. This is called implied consent. For instance, if a person tries to overdose on drugs to commit suicide and they refuse treatment, the paramedics cannot touch the patient. Once they pass out they can claim implied consent and start treatment. The basis is that the person, if they were conscious and able to give consent, would give consent to save their life. Does this apply to unapproved and untested drugs like PolyHeme though? I doubt if such an argument would hold up. A person would probably give consent if they knew, or had reason to believe, that the drug or treatment had been thoroughly tested and was an approved treatment. A reasonable person is not likely going to consent to an unproven, and potentially dangerous unapproved drug or treatment. Especially when safer and proven therapies exist. Northfield Laboratories claims to have followed CFR 50.24 explicitly. I disagree, based on the facts that they never completed previous trials, their product has a higher death rate than controls and those receiving blood, they have not informed the public of their testing, or the possible dangers of the therapy, and I don’t see any evidence that they are really trying to obtain consent as is required by law.

Patients were allowed to opt out of the test in case they suffered a severe trauma that would leave them unable to give consent. To do so though they had to obtain a blue plastic bracelet from the company that they had to be wearing at the time paramedics arrived. In order to get the bracelet the person would first have to be aware of the test. Many people were not aware that the test was going on until testing had almost been completed. And as previously pointed out, people that did not follow the media, or who had no access to the media, would have still been uninformed about the testing. The same could apply to those who do not speak English. Even if the story came on the TV news, it does not mean they would understand what the test was about, or how to opt out.

So what are the potential side effects of PolyHeme? Previous hemoglobin products have all been shown to cause kidney damage, liver damage, high blood pressure, and inflammation of the arteries. There is also concern that allergic reactions may occur. Northfield Laboratories claims that these adverse effects are not possible, and their product is safe. Other researchers disagree. And Northfield Laboratories has not had the greatest track record of being honest to the public about the safety record of their product. For instance when they tried to suppress the fact that 10 patients died within one week of receiving their product, and no patients receiving real blood died. And this study was halted early. Would more deaths have occurred if the study had continued its full duration? Other adverse affects reported by the use of PolyHeme were significant increases in the rate of heart attacks, arrhythmias, and pneumonia.

Cities listed as participants in the test are : San Diego, California; Denver, Colorado; Newark, Delaware; Macon, Georgia; Maywood, Illinois; Indianapolis, Indiana; Kansas City, Kansas; Lexington, Kentucky; Detroit, Michigan; Rochester, Minnesota; Durham, North Carolina; Cleveland, Ohio; Cincinnati, Ohio; Dayton, Ohio; Bethlehem, Pennsylvania; Hershey, Pennsylvania; Memphis, Tennessee; Johnson City, Tennessee; Houston, Texas; San Antonio, Texas; Salt Lake City, Utah; and Morgantown, West Virginia . The clinics and hospitals listed as participating were:

UC San Diego Medical Center, San Diego, California

Scripps Mercy, San Diego, California

Denver Health Medical Center, Denver, Colorado

Christiana Hospital, Newark, Delaware

Medical Center of Central Georgia, Macon, Georgia

Loyola University Medical Center, Maywood, Illinois

Wishard Memorial Hospital, Indianapolis, Indiana

Methodist Hospital of Indiana, Indianapolis, Indiana

University of Kansas Medical Center, Kansas City, Kansas

University of Kentucky Medical Center, Lexington, Kentucky

Detroit Receiving Hospital, Detroit, Michigan

Sinai Grace Hospital, Detroit, Michigan

The Mayo Clinic, Rochester, Minnesota

Duke University Medical Center, Durham, North Carolina

MetroHealth Medical Center, Cleveland, Ohio

University of Cincinnati Medical Center, Cincinnati, Ohio

Miami Valley Hospital, Dayton, Ohio

St. Luke’s Regional Resource Trauma Center, Bethlehem, Pennsylvania

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania

University of Tennessee-Memphis, Memphis, Tennessee

Johnson City Medical Center, Johnson City, Tennessee

University of Texas Health Science Center, San Antonio, Texas

University of Utah Health Sciences Center, Salt Lake City, Utah

LDS Hospital, Salt Lake City, Utah

Virginia Commonwealth University Medical Center, Richmond

West Virginia University/Jon Michael Moore Trauma Center, Morgantown, West


Other hospitals that stopped participating in the study before it was completed are the Albany Medical Center, Albany, New York; Lehigh Valley Hospital, Allentown, Pennsylvania; Brooke Army Medical Center, Fort Sam, Houston, Texas; Memorial-Hermann Hospital, Houston, Texas; Sentara Norfolk Hospital, Norfolk, Virginia; and Inova Fairfax Hospital, Falls Church, Virginia.

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