- Posted October 17, 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
In 2013:THE UNSUSPECTING PATIENTS WITH NO FDA PROTECTION DURING CLINICAL TESTING OF DEVICES
There are human experiments that are currently being run at top hospitals across the country without informed consent while patients are under general anesthesia. Patients are not given the opportunity to provide informed consent for the testing of newly developed heart devices.
A recently published expose, The Myxo File Part I -XII, published on Amazon.com and Kindle Direct Publishing provide the documents from the FDA, communications with the White House and Congress to try and get help for the patients. So far, the requests for an investigation, over 5 years still no response. President Barak Obama, inquired into the situation twice but the FDA is not reporting to the White House, the over 4,000 adverse events and over 645 deaths from these heart devices.
Communications and letters from the White House are in the Myxo File Part II.
The Company reported to the SEC that a new device was being invented for myxomatous mitral valve disease. The company provided a similar disclosure to the US patent office regarding the 40 new claims for a new invention. However, the FDA was not informed of the clinical trial until 2 years after the initial prototypes were manufactured and the disclosure was from a patient.
The Honorable Senator John McCain. First Lady Obama, and Senator Richard Lugar are the only Government Individuals who wrote on behalf of the patients in Illinois and Indiana to the FDA.
Patients are suffering while under general anesthesia. The Myxo File Part I –XII, demonstrates the heart attack, cardiac arrest and repeat surgery in patients who never agreed to be guinea pigs.
These experiments would benefit the company and the inventor in royalties and profits, but the facts regarding the adverse events were left out of the final scientific publication. The laws that protect human subjects date back to World War II after the Nuremberg Trials, and are currently protected under the Common Rule. HHS, FDA, NIH, are responsible for the protection of these human lives in the United States and no response from these US Federal agencies to help the victims of illegal surgical human experiments.
Human beings have the right to know if they receive an experimental device while under general anesthesia.
Nalini Rajamannan, Christian Newswire December 2012
"NAZI MEDICAL EXPERIMENTS
Result of a medical experiment on a prisoner. Buchenwald concentration camp, Germany, date uncertain.
— US Holocaust Memorial Museum
During World War II, a number of German physicians conducted painful and often deadly experiments on thousands of concentration camp prisoners without their consent.
Unethical medical experimentation carried out during the Third Reich may be divided into three categories...."
"The second category of experimentation aimed at developing and testing pharmaceuticals and treatment methods for injuries and illnesses which German military and occupation personnel encountered in the field. At the German concentration camps of Sachsenhausen, Dachau, Natzweiler, Buchenwald, and Neuengamme, scientists tested immunization compounds and sera for the prevention and treatment of contagious diseases, including malaria, typhus, tuberculosis, typhoid fever, yellow fever, and infectious hepatitis. The Ravensbrueck camp was the site of bone-grafting experiments and experiments to test the efficacy of newly developed sulfa (sulfanilamide) drugs. At Natzweiler and Sachsenhausen, prisoners were subjected to phosgene and mustard gas in order to test possible antidotes.?"
See CNN Ireport Confirming the Data of the Official Launch of the Device on the US market January 2007
The device was tested from March 2007 through December 2006 during the validation stage of Testing the device as per the Design Controls fas per FDA regulations for the evoluation of a device in the Design Master Record or “justification to file"
DTCI: 'Justification to file' on medical device review
John P. Twohy , From DTCIJune 8, 2011
See CNN Ireport for Lack of Informed Consent:
Wall Street Journal, Mundy and Favole 2009
See CNN Ireport for Clinical Study:
See CNN Ireport for the Falsified Data and Heart Attack Missing from the FDA Compliance Review:
Northwestern University Response to the Investigation:
See CNN ireport:
The Response required by HHS as posted on the Northwestern University Website and the Invitation to the President of the University to protect the Innocents as delivered in the Myxo file Part IV: