Houston Participates in Controversial Phase III Clinical Trials for Blood Substitute PolyHeme

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Researched by Industrialinfo.com (Industrial Information Resources, Incorporated; Houston, Texas) Northfield Laboratories (NYSE:NFLD) (Evanston, Illinois) has chosen twenty cities across the country for clinical trials of its blood substitute, PolyHeme. Hoping to reach a minimum of 720 patients nationwide, the company is counting on at least 50 from the Houston area. The University of Texas Medical School and Memorial Hermann hospital are conducting the local trials, which basically involve giving a patient PolyHeme, rather than the traditional emergency treatment of saline. The controversy that has arisen over the trials deals with the issue of patient consent.

The current program allows waiving test subjects' informed consent, a practice allowed by the Food and Drug Administration's guidelines, which permit such waivers in life-threatening situations. American Medical Association policy also allows waiving informed consent for emergency medicine research if eight conditions are met, including informing a community that the research is taking place. Potential patients have the option to opt out of the study by informing the local host institutions, which will then provide a wristband stating their preference.

Patients receiving PolyHeme will obviously be unable to provide prior consent due to the crisis circumstances in which the product will be administered. Patients will not learn of the possible risks and side effects until after being injected. Traditionally, ambulance paramedics and emergency rooms inject saline, but the trials hope to show that the use of PolyHeme, which like real blood carries oxygen, will help prevent deadly shock and damage to internal organs and the brain.

In the Houston trials, eligible adult patients will be randomly assigned to receive infusions of either PolyHeme or the current standard saline treatment. Treatment will begin before arrival at the hospital, either at the scene of the injury or on the way to Memorial Hermann Hospital’s Emergency Center via LifeFlight, and will continue during a 12-hour post injury period in the hospital.

Some bioethicists have questioned the validity of these trials because the treatment can go on for hours, long after the immediate threat has passed. They argue that the main reason for the waiver, that satisfactory treatment is not immediately available, is no longer true once patients are admitted to a hospital and have access to blood. Rules for the study do stipulate that family members must be notified of patient enrollment as soon as possible and be offered the choice of allowing the patient to continue in the study or to withdraw. If they choose to withdraw, there will be no disruption in care.

None of the experts disagree with the need for a successful blood substitute in emergency medicine, as traumatic injury is a leading cause of death, especially in people under 35. Many die from blood loss and shock. Brain, liver and kidney failure can kill a patient, too. These factors contribute to the product’s potential value on the battlefield. The product would also help fill the gap in non-emergency situations when real blood is in short supply.

If the trials prove successful, Northfield believes the product could be on the market by 2006. As reported by Industrialinfo.com in September of 2004, the company is considering an expansion of its facility in Mount Prospect, Illinois. Northfield would increase production of PolyHeme to a commercial-scale capacity of 85,000 units per year.

Other, similar transfusion substitutes, have suffered setbacks of their own. Preliminary testing in the United States of an oxygen-carrying blood substitute that uses cow's blood as its base was delayed by federal government safety concerns earlier this year. The human testing of another substitute was halted in 1998 when patients died at a higher rate than those who were given saline injections.

Northfield claims PolyHeme is compatible with all blood types, is free of viruses and stores longer than real blood, which requires careful refrigeration. Real blood can be stored about 45 days. PolyHeme, which is made from blood hemoglobin, keeps for weeks, even when unrefrigerated and it lasts at least a year when chilled. In five earlier limited clinical trials of PolyHeme involving about 300 people, survival rates increased and no dangerous side effects were reported, according to Northfield.

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