"Five of the 31 hospitals in the trauma study followed suit, but well after many trauma patients had been treated," the paper noted.
In his letter, Senator Grassley told the FDA to address the issue "by providing the public with meaningful information related to what it should already have known about the PolyHeme Study."
In addition, by March 8, 2006, he instructed the agency to provide his Committee with a detailed briefing regarding the study.
"Over the next few days," Senator Grassley wrote, "my Committee staff will contact your staff with more specific requests for information, but at the minimum your staff should be prepared to address the following issues related to the PolyHeme Study:
1. What oversight, if any, has FDA conducted related to the PolyHeme Study?
2. What consultation with representatives of the community was conducted?
3. What public disclosure to communities was conducted prior to initiation of the PolyHeme Study?
4. Were known adverse events, including but not limited to those reported in the WSJ, disclosed with the risks and expected benefits information?
5. Has Northfield Laboratories, Inc., met all regulatory reporting requirements related to its PolyHeme product, including but not limited to timely reporting of all adverse events?"
He also asked the FDA to provide a detailed list and summary of all clinical trials conducted since January 1, 1996, under the FDA regulation governing exception from informed consent requirements.
In regard to the current study, Northfield says an independent committee monitoring the study reviewed reports of death and other serious problems four times, and each time recommended the trial continue unchanged, according to Reuters News on February 24, 2006.
For more information for injured parties go to Lawyers and Settlements
http://www.lawyersandsettlements.com/articles/clinical_trial.html
By Evelyn Pringle
evelyn.pringle@sbcglobal.net
In his letter, Senator Grassley told the FDA to address the issue "by providing the public with meaningful information related to what it should already have known about the PolyHeme Study."
In addition, by March 8, 2006, he instructed the agency to provide his Committee with a detailed briefing regarding the study.
"Over the next few days," Senator Grassley wrote, "my Committee staff will contact your staff with more specific requests for information, but at the minimum your staff should be prepared to address the following issues related to the PolyHeme Study:
2. What consultation with representatives of the community was conducted?
3. What public disclosure to communities was conducted prior to initiation of the PolyHeme Study?
4. Were known adverse events, including but not limited to those reported in the WSJ, disclosed with the risks and expected benefits information?
5. Has Northfield Laboratories, Inc., met all regulatory reporting requirements related to its PolyHeme product, including but not limited to timely reporting of all adverse events?"
He also asked the FDA to provide a detailed list and summary of all clinical trials conducted since January 1, 1996, under the FDA regulation governing exception from informed consent requirements.
In regard to the current study, Northfield says an independent committee monitoring the study reviewed reports of death and other serious problems four times, and each time recommended the trial continue unchanged, according to Reuters News on February 24, 2006.
For more information for injured parties go to Lawyers and Settlements
http://www.lawyersandsettlements.com/articles/clinical_trial.html
By Evelyn Pringle
evelyn.pringle@sbcglobal.net
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