"Why should Americans have to wear a bracelet at all times to protect themselves from a government-sanctioned medical experiment if they happen to get into a car accident?" he asked the FDA.
"I suspect many people, if they knew this," Senator Grassley noted, "might reasonably ask, "where do I get my wristband?"
This question is not readily answerable according to the Senator, "it's not apparent from any information on the FDA's website," he said.
Researchers at Legacy Health System and Oregon Health & Science University in Portland, Oregon suspended their plans to test the blood substitute after attempts to get local approval for the experiment were unsuccessful for 2 years.
The WSJ reported that, in an earlier clinical trial of PolyHeme, 10 out of 81 patients suffered heart attacks within a week of receiving the substitute and that 2 of those people died.
Besides the heart attacks and deaths, the trial suggested the PolyHeme was linked with other adverse events such as heart rhythm aberrations and pneumonia. These events occurred in 54% of the PolyHeme patients versus 28% in the control group, according to Northfield's internal documents.
The previous study differs from the current study in that patients in the first study were not trauma patients, they were undergoing surgery to repair aneurysms in their aortas and consented to participating in the study. In the first study, patients in one group received PolyHeme and patients in the control group received real blood.
In the second half of 2001, "Northfield abruptly shut down the study, explaining in a Securities and Exchange Commission filing that it was taking too long to complete," the WSJ reports. The paper says Northfield failed to make the results of the study public.
Northfield's chief executive, Steven Gould, says it has not been proven that the adverse events in the trial were caused by PolyHeme and claims the heart attacks may have been caused by doctors who pumped too much fluid into patients, when adding PolyHeme and real blood.
William Hoffman, chief of the cardiac-surgery intensive-care unit at Massachusetts General Hospital in Boston, told the WSJ that substitutes in a class that includes PolyHeme, are associated with heart attacks and strokes. "It is self-serving and potentially misleading to associate harmful effects with something other than the test drug," he said.
Doctors who took part in the first study have questions but said Northfield restricted access to the full data so they only knew what happened to their own patients.
At the University of Pennsylvania, Dr. Fairman told the WSJ that he and a colleague, Albert Cheung, repeatedly called Dr Gould at Northfield. "We said, 'Let's sit down and write up the data,' " Dr. Fairman recalls. "He wouldn't do it."
Dr. Cheung proposed a meeting of doctors at the 21 hospitals that had taken part in the study and says Dr Gould agreed to the meeting, but then cancelled it at the last minute.
T.J. Gan, a Duke University anesthesiologist involved in the study, told the WSJ he called Northfield three years ago to ask if results had been published and Dr. Gould told him, "Someone's working on it."
Northfield issued a statement saying company officials do not recall the specifics of any discussion about a meeting with Dr Cheung or the conversation with Dr Gan. It denies that it "resisted publication" but says: "We did not allocate resources to publication. In retrospect, reporting the full study results earlier would have been better."
"Last year," according to the WSJ, "the FDA required Northfield to mention on its Web site "serious cardiovascular adverse experiences" with PolyHeme."
"I suspect many people, if they knew this," Senator Grassley noted, "might reasonably ask, "where do I get my wristband?"
This question is not readily answerable according to the Senator, "it's not apparent from any information on the FDA's website," he said.
Researchers at Legacy Health System and Oregon Health & Science University in Portland, Oregon suspended their plans to test the blood substitute after attempts to get local approval for the experiment were unsuccessful for 2 years.
Besides the heart attacks and deaths, the trial suggested the PolyHeme was linked with other adverse events such as heart rhythm aberrations and pneumonia. These events occurred in 54% of the PolyHeme patients versus 28% in the control group, according to Northfield's internal documents.
The previous study differs from the current study in that patients in the first study were not trauma patients, they were undergoing surgery to repair aneurysms in their aortas and consented to participating in the study. In the first study, patients in one group received PolyHeme and patients in the control group received real blood.
In the second half of 2001, "Northfield abruptly shut down the study, explaining in a Securities and Exchange Commission filing that it was taking too long to complete," the WSJ reports. The paper says Northfield failed to make the results of the study public.
Northfield's chief executive, Steven Gould, says it has not been proven that the adverse events in the trial were caused by PolyHeme and claims the heart attacks may have been caused by doctors who pumped too much fluid into patients, when adding PolyHeme and real blood.
William Hoffman, chief of the cardiac-surgery intensive-care unit at Massachusetts General Hospital in Boston, told the WSJ that substitutes in a class that includes PolyHeme, are associated with heart attacks and strokes. "It is self-serving and potentially misleading to associate harmful effects with something other than the test drug," he said.
Doctors who took part in the first study have questions but said Northfield restricted access to the full data so they only knew what happened to their own patients.
At the University of Pennsylvania, Dr. Fairman told the WSJ that he and a colleague, Albert Cheung, repeatedly called Dr Gould at Northfield. "We said, 'Let's sit down and write up the data,' " Dr. Fairman recalls. "He wouldn't do it."
Dr. Cheung proposed a meeting of doctors at the 21 hospitals that had taken part in the study and says Dr Gould agreed to the meeting, but then cancelled it at the last minute.
T.J. Gan, a Duke University anesthesiologist involved in the study, told the WSJ he called Northfield three years ago to ask if results had been published and Dr. Gould told him, "Someone's working on it."
Northfield issued a statement saying company officials do not recall the specifics of any discussion about a meeting with Dr Cheung or the conversation with Dr Gan. It denies that it "resisted publication" but says: "We did not allocate resources to publication. In retrospect, reporting the full study results earlier would have been better."
"Last year," according to the WSJ, "the FDA required Northfield to mention on its Web site "serious cardiovascular adverse experiences" with PolyHeme."
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