- Posted October 8, 2013 by
This iReport is part of an assignment:
Shutdown over: What next?
- MORGAN LEWIS RESPONSE TO THE SENATE FINANCE COMMITTEE CONFIRMING THE FACT THAT THE OUTCOMES REGISTRY HAD NOTHING TO DO WITH THE MYXO ETLOGIX CLINICAL TRIAL
- 150 years later, newspaper retracts editorial panning Gettysburg Address
- OHRP FDA REGULATIONS FOR INFORMED CONSENT CLASSIFIES INVESTIGATIONAL DEVICES SUCH AS THE MYXO ETLOGIX MODEL 5100 UNDER THE LAWS WHICH REQUIRE FULL INFORMED CONSENT:
- FDA CONGRESSIONAL OFFICE ON JULY 16, 2009 OFFICIALLY CATAGORIZES THE MYXO ETLOGIX MODEL 5100, MANUFACTURED BY EDWARDS LIFESCIENCES AS INVESTIGATIONAL AND OF SIGNIFICANT RISK
- Northwestern University and Northwestern Memorial Hospital Elements of Informed Consent : HIPPA WAIVER DOES NOT APPLY TO FDA STUDIES subject to the FDA regulations at 21 CFR 50
American Recovery and Reinvestment Act 2009: Northwestern University Violates Whistleblower Protections for ARRA awardee
The denial of tenure is the path to the truth
Statement from Nalini M. Rajamannan, MD, FACC, FAHA
As a special Government employee, NIH grantee and an ARRA award grantee, my reporting to the University was protected under federal laws for whistleblower.
The truth surrounding the events, which occurred between March 2006-January 2007 while the surgeon, and the device manufacturer performed validation testing of the experimental prototype the McCarthy Annuloplasty Ring model 5100.
The surgeon made the decision to test patients, after they were under general anesthesia as per his own statement to theheart.org in Oct. 2008 without informed consent from the patients.
Northwestern University signed the federal wide assurance to Health and Human Services, which in turn assures the United Nations and the International Tribunal of Hague, that the Institution would protect the innocent patients against experimentation without informed consent.
These laws were written after WWII Nuremberg trials to protect the rights of Human Beings to full informed consent to avoid the atrocities of the holocaust.
I will continue to advocate for the innocent victims until each and every one of the patients who received the IMR, The Myxo ETlogix and any other unregistered, non-FDA approved device is informed of the experimentation to gain market share and future clearance and approvals of the medical devices.
The laws are clear regarding my reporting responsibility and the Institutional responsibility once I report.
This responsibility should be a five minute response to protect the patients, not a 6 year denial and reliance upon an email stating the device was approved in March 2006, while the device manufacturer reported to the SEC that the device was not launched onto the US market until January 2007- ten months after the validation study for the design controls for the internal design history file.
“Northwestern policy prohibits the taking of retaliatory action against anyone for reporting or inquiring about potential breaches of University policy or for seeking guidance on how to handle suspected breaches. The identity of confidential sources will be protected to the extent consistent with the needs of an inquiry or investigation. Those individuals who provide information in good faith about questionable conduct will be protected against reprisals.
In addition, Northwestern has specific whistleblower protections to comply with American Recovery and Reinvestment Act of 2009 (ARRA) awards.”
Sign the petition to support the health care needed for these patients:
Please review the following CNN ireports providing the evidence:
Each and every federal and local document is available online in the recently published Myxo Files on Amazon.com by Nalini M. Rajamannan, MD
The other publications that have been written to date include:
The Chicago Magazine: Breakthrough Medicine
Project on Government Oversight: PAUL THACKER and BRYAN RAHIJA
Doctors Experimenting on Humans: Five Questions with Dr. Nalini Rajamannan
TheHeart.org Articles: Shelley Wood and Reed Miller
The Myxo ring mix-up - Medscape
The Chicago Tribune: Deborah Shelton
And Jason Grotto
The Chronicle of Higher Education: Paul Basken
Top Secret Writers: Kathleen Roberts
The Wall Street Journal: Mundy and Favole