- Posted March 15, 2014 by
- FDA Issues Warning Letter to Edwards Lifesciences, for misbranding of Myxo ETlogix annuloplasty Ring
- Northwestern University 5pm ET Deadline Today to Respond to Senate Judiciary Committee Inquiry Regarding Unauthorized Human Experimentation
- Grassley not satisfied with the responses, continues to press the issue
- Medical Institutions Identified in Secret Testing in Senate Investigation FDA not Responding: Part I
- Part II: Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
Human Experimentation without informed consent is at the center of a Senate Judicary Committee Investigation of a Prestiguous Academic University, which was reopened after violations of USC 1001 of the Federal Code.
"Human Experimentation without informed consent is at the center of a Senate Judicary Committee Investigation of a Prestiguous Academic University, which was reopened after violations of USC 1001 of the Federal Code.
Chicago, IL (PRWEB) March 10, 2014
Since 2008, the Honorable Senator Grassley has investigated Northwestern University for allegations surrounding Human Experimentation without Informed consent. According to FDA documents, 667 patients received the non-approved FDA devices from 2006-2008, prior to FDA approval.
The FDA approval came only after the device was tested in 100 unsuspecting patients during open heart surgery. The results of the study published in the Harvard Based Surgical Journal, Journal of Thoracic and Cardiovascular surgery in 2008 claimed " informed consent." Recent publically available court documents from Cook County demonstrate that the patients consent was waived.
Myxo Ring Controversy Reopened with New Questions From Sen Grassley
Some of these critical documents were never provided by Northwestern University to the Honorable Senator Grassley during the Senate Finance investigation, and now are a subject of reopened Senate investigation as of March 4, 2014. The lack of disclosure violates USC 1001.
The Chronicle of Higher Education published the Senate Judiciary investigation today in a report entitled: Northwestern U. Gets Renewed Grilling Over Unauthorized Tests on Patients
Sen. Charles E. Grassley, an Iowa Republican, has accused Northwestern U. of withholding key documents from an inquiry into allegations that its chief of cardiac surgery experimented on unsuspecting patients. By Paul Basken
For years, the Senate Finance Committee investigated the testing of the non-approved Devices in patients during open heart surgery without informed consent. However, key documents surrouding the patients' testing were withheld from the Senate Committee, the FDA, and the patients.
Northwestern University Board of Trustees have known about the human experiments, since July 2009. Yet the board, has not set up a meeting with the former Northwestern Professor, Dr. Nalini M. Rajamannan, to help inform the patients, provide proper health care for the patients, and restore the integrity of this great University.
The Myxo Files released on Amazon.com contain summaries, and documents from the Public Domain, to try and get help for the innocent unsuspecting patients.
See CNN Ireports for all reports to date on this critical and controversial subject:
For the original version on PRWeb visit: http://www.prweb.com/releases/2014/3/prweb11647160.htm "