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Archives | (April 2003)
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FEDERAL FRANKENSTEINS: PART TWO SCIENTIFIC AMBITION ECLIPSES ETHICS
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------------------------------------------------------------------ Page 5 of 6 Of course, asking questions is of little value if the answers conceal the truth, and a number of key facts were concealed from Hamilton: She was not told that previous participants in the experiment had died. She was not told that the Center and the researchers had a financial interest in the drug being tested. She was not told that one of the key “rescue drugs” would not be available in IV form. She was not told that the same doctors running the experiment were about to publish an article saying the drugs they proposed to use on her might actually do more harm than good. At 7 AM on January 7, 1993, Kathryn Hamilton was given the first, ultimately lethal dose of busulfan. Almost immediately she developed severe nausea. Virtually every time she took the dose of PTX that was supposed to protect her organs, she threw it up. When her family asked why the PTX wasn’t being administered in its IV form they were told that the FDA had withdrawn approval of the drug. When questioned about why researchers at The Hutch hadn’t obtained permission to use the IV form of PTX they said it would have involved too much paperwork. Yet, the truth is that a simple phone call to the FDA could have provided that permission on an emergency basis. They just didn’t want to bother. Nine days after being admitted to The Hutch Hamilton received her stem cell transplant. Her condition continued to deteriorate. Her liver was damaged and she had trouble breathing. She began to bleed from her eyes, ears and nose. Her kidneys began to fail. On February 19, 1993 she died in agony. Six days later, the researchers running the experiment published an article in the journal “Blood.” It said PTX didn’t work. But that didn’t stop the research. The researchers claimed that Hamilton’s death proved nothing. It didn’t prove that the combination of PTX and Cipro would protect against damage from chemotherapy or that it wouldn’t. Protocol 681 continued for five more years until it was finally shut down in 1998. Ultimately four women would die of so-called “regimen-related toxicity.” In other words they were killed by the treatment that was supposed to save them. Normally regimen-related deaths are extremely rare, but in the case of Protocol 681, it claimed one in seventeen subjects. |
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