FDA to Consider Another Artificial Blood Experiment Without Subjects' Consent

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July 11, 2006 9:55 AM

With medical ethicists raising alarms, the Food and Drug Administration meets behind closed doors this week for secret deliberations  on whether to allow an artificial blood  substitute, Hemopure, to be tested in trauma patients without their knowledge or consent.   

The proposed medical experiment would be similar to one already underway in 27 American cities involving a product called Polyheme, being conducted by Northfield Labs.

U.S. Senator Charles Grassley (R-IA) said the FDA should think twice about green-lighting such controversial trials, given that the first non-consent trial involving a blood substitute product ended disastrously.  According to Senator Grassley, "It seems to me it raises a very red flag that FDA ought to be considering."

In 1996, the FDA adopted a regulation that permitted experimental testing on humans without their consent in the field of emergency medicine research.  The rules marked a departure from a doctrine articulated in the post-World War II Nuremberg Code that stated, "The voluntary consent of the human subject is absolutely essential."  The doctrine was adopted in response to the hideous human experiments conducted by Nazi doctors.  The rationale behind the change in the FDA rules was that advances in emergency medicine and treatment would be nearly impossible if consent had to be obtained in advance from seriously injured trauma patients.

The first company given approval by the FDA to use the new waiver was the giant medical corporation Baxter International, which was developing an artificial blood product called HemAssist.  In 1997, Baxter began a clinical trial that involved giving HemAssist to non-consenting trauma patients within an hour of arriving at the hospital.  The trial was halted after disastrous results emerged -- out of the 52 patients given HemAssist, 24 died, a mortality rate of 46.2 percent.  The control patients who received saline solution and real blood had a mortality rate of just 17.4 percent.  Baxter has said there was no conclusive evidence that HemAssist was responsible for the greater number of deaths, but the product is no longer in development.

Safety concerns have also been raised about Polyheme after it was discovered that a previous trial on consenting surgery patients was stopped after 54.3 percent of the patients receiving Polyheme suffered a serious adverse experience versus 28.2 percent in the control group.  Ten  out  of the  81 patients who received Polyheme suffered heart attacks, two of whom died; there were no heart attacks among the patients in the control group.

Northfield Labs has attributed the results to a flawed trial design where doctors administered too much fluid to patients in the experimental group.  Northfield has also noted that an independent monitoring committee has periodically examined the safety data from the current trauma trial and has allowed it to proceed.

Biopure, the maker of Hemopure, and the U.S. Navy have asked the FDA to allow a trial where more than 900 badly bleeding accident victims would be given either Hemopure or saline solution by paramedics.  However, according to a recent Wall Street Journal article, the safety of Hemopure has been questioned after a past trial revealed higher incidents of heart problems in test subjects.  A Biopure spokesperson told the Journal that the problems "weren't necessarily linked to Hemopure" and that the product "has an acceptable safety profile."

If approved, an artificial blood product would revolutionize emergency medicine. Unlike real blood, artificial blood has a long shelf life and doesn't need to be cross-matched to a patient's blood-type; currently paramedics only administer saline solution to severely bleeding trauma patients.  But despite decades of research and development, artificial blood products have yet to be approved by the FDA for widespread use.


Click here to read the FDA's waiver of informed consent rules (21 CFR. 50.24).