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Medical experimentation

New government rule may allow medical experiments on humans without their consent

Thursday, September 07, 2006 by: NewsTarget
Tags: medical experimentation, medical ethics, HemAssist


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(NewsTarget) In 1996, a regulation (21CFR50.24) was approved that contained a loophole allowing experimental testing of a blood substitute product -- HemAssist -- on emergency trauma patients without their knowledge or consent, but the experiment was terminated when more HemAssist patients died than patients under standard care.

Ten years later, after the development of HemAssist has been abandoned, a similar experiment using blood substitute Polyheme was being conducted in 27 cities across the United States from July 7 to July 31, with a blue wrist band provided by manufacturer Northfield Laboratories Inc. being the only way to "opt out." Outrage at these trials has pushed the federal government to reconsider the loophole.

The FDA -- lambasted by the medical community for allowing the Polyheme trials to occur despite the reservations expressed by experts -- has stated it will take "a close look" at how the blood substitute is being used, and release a draft of guidelines on non-consent trials that will "broaden the discussion of community consultation and public disclosure" and "clarify terminology used in regulations that have been difficult to interpret."

The FDA has scheduled a public hearing on the matter at the University of Maryland Shady Grove Center on Oct. 11.

"It is appropriate that we review the regulation and get the perspectives of those who participated in such studies to make sure that emergency research is being carried out in a scientifically sound and ethical manner," said Dr. Janet Woodcock, FDA deputy commissioner for operations.

"Under no circumstances should human beings be turned into guinea pigs for medical experiments without their clear consent," countered Mike Adams, a health freedom advocate and critic of the medical industry's practice of using adults and children for medical experiments. "This practice harkens back to the days of Nazi Germany where, not coincidentally, companies like Bayer routinely engaged in mass medical experimentation on prisoners," he said. "This is a fundamental human rights issue, and both the FDA and Big Pharma have consistently shown little regard for human rights, especially when such rights get in the way of corporate profits."

"The false justification that 'this is for the patients' own good' is exactly the same twisted logic once fronted by the Nazis to justify their own inhumane medical experiments," Adams added.

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