- Posted March 21, 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
Northwestern University 5pm ET Deadline Today to Respond to Senate Judiciary Committee Inquiry Regarding Unauthorized Human Experimentation
CHICAGO, March 21, 2014
CHICAGO, March 21, 2014 /PRNewswire/ - Allegations continue surrounding the testing of two annuloplasty rings, invented by the chief of cardiac surgery, Dr. Patrick McCarthy at Northwestern University, the Myxo Ring, and the IMR Ring (invented by McCarthy, and colleagues). Both rings were implanted in patients, allegedly, without their consent. These rings considered to be similar to the pre-existing devices, which never underwent FDA approval or FDA registration for legal sales on the US market according to FDA congressional letters as reported in the Chicago Tribune, and the project of government oversight, POGO. This line of valve rings, have resulted in over 4000 adverse events, including 645 deaths according to the FDA MAUDE database.
In a letter sent to Northwestern on March 5, 2014, the Senate Judiciary committee requests a response to documents surrounding this unauthorized human experimentation which took place at Northwestern Memorial Hospital. The deadline for Northwestern University to respond to this request is today March 21, 2014.
"On December 8, 2008 and September 30, 2009, Senator Grassley wrote Northwestern University regarding troubling allegations that the Myxo-ETlogix 5100 Ring(Myxo Ring), an annuloplasty ring used in heart valve repair, had not been cleared for marketing by the Food and Drug Administration(FDA) before it was implanted in patients as part of an outcomes study."
The senator notes the inadequacies in the responses from the Northwestern entities, including contradictory statements regarding the similarity of the Myxo Ring to preexisting devices, Second, is not clear whether patients received sufficient notice of safety questions. Most alarmingly was the documents that were withheld by the University including a waiver (1532-004), which waived the patients right to know they were receiving FDA Devices as part of pre-clinical testing necessary for the eventual 2009 clearance of the devices. When asked to comment on behalf of Northwestern Entities, Senior VP for Northwestern University Alan Cubbage, declined to comment why Northwestern did not stop the testing of the devices in 2007, after the Former Valve Director, Dr. Nalini M. Rajamannan, brought it to the University's attention according to multiple news sources, the Chicago Tribune, Theheart.org, the Chronicle of Higher Education, Top Secret Writers, and AP Chicago.
Furthermore, in a FDA Congressional letter sent to Senator Richard Lugar(IN), indicates that at least 667 patients received the Myxo ETlogix devices, and that the waiver which exempted patients from knowing they were being tested on, allowed the FDA to clear not one but two heart valve rings, the Myxo and the IMR rings.
When asked to comment, the FDA said, "we relied upon Northwestern Memorial Hospital, CEO letters to patients regarding the status of the device." The letter sent by NMH CEO to the Myxo patients in January 2009, states that " we do not consider the device to be experimental," during the exact month that both devices, the Myxo and the IMR were under a voluntary recall by the FDA.
To this date, the voluntary recall has not been reported to the thousands of patients who received these experimental devices between 2003-2008.
In 2011, the head of the device section for the FDA, Dr. Jeffrey Shuren, confirmed to the Chicago Tribune, that both devices were experimental prior to 2009.
Link to the Senate Judiciary Letter to Northwestern University dated
SOURCE PR Newswire and Robert Amaefule and Oscar Delgado"