- Posted February 26, 2013 by
This iReport is part of an assignment:
- The Myxo Files Published on Amazon.com Reveals the Cover-up of Human Experimentation with non-Approved FDA devices in Humans Without Informed Consent
- Experimental Testing of Non-approved FDA devices using Medicare dollars and Private Insurance at NU
- The Myxo File Part III, Biographical story of a Cardiologist requesting help from the President, Barack H. Obama, for her patients in Chicago
Myxo File Part IV reveals the truth behind statements made by Northwestern University to the Senate Finance Committee
The Myxo File Part IV invites Northwestern University President Morton Schapiro to help the innocent victims of illegal human experimentation.
Below are the direct quotes from the Responses sent to the Senate Finance committee and the youtube video invitation.
1) McDermott, Will and Emery law firm sent responses to the Senate Finance committee: The letter sent by Dean Harrison to the patient in January 2009 which is included in the responses to the Senate Finance Committee indicating that Northwestern informed the patients that the device was under a voluntary recall. There is no indication in the letter of January 2009 that there was information sent to the patients that the device was under a voluntary recall.
2) Northwestern University stated to the Senate Finance Committee in responses as written by Morgan Lewis, Counselors at Law, that Northwestern has no documents responsive to the FDA status of the Myxo ETLogix 5100 Ring because Northwestern is not involved in the clinical activities as described above.
However, the University did reveal to myself in the office of research integrity documents that the IRB that is a under the federal wide assurance governed by HHS, that there was the patient registry that at least one patient signed to give the inventor informed consent to test the device in the patient. However, the document did not reveal to the patient any information regarding the testing of the device, the experimental nature of the device, the device was undergoing modifications in the patent application and that the device was reported to the SEC as being tested in the year 2006, prior to US market launch in the year 2007.
3) The University in response to the Senate Finance committee as written by Morgan Lewis, Counselors at Law, "To clarify, the Myxo ETlogix 5100 Ring was not 'use[d] in the cardiac surgery outcomes registry.' The registry was not aimed at a particular device; rather it was a registry of subjects with cardiovascular disease requiring surgical intervention."
The Office of Research Integrity in all of the three official Northwestern statements to the patient and to myself, state that the registry did provide patients the informed consent to test the devices in their hearts during open heart surgery chapter 4 of the Myxo File Part IV.
My hope is that the President Schapiro of Northwestern University will accept my invitation to meet and provide quickly the proper health care for the patients. I will continue to advocate for these innocent victims as this is my responsibility to my Roman Catholic Faith(+ JMJ-OLMC).