- Posted July 27, 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
- Part II: Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
- Part I: Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
Medical Institutions Identified in Secret Testing in Senate Investigation FDA not Responding: Part I
By Rob Amaeule
(Washington, DC) Senate Judiciary Committee, Senator Charles Grassley(IA) is still “monitoring” an FDA investigation he reopened in 2014 after it was brought to his attention that important documents were withheld from him by Northwestern Memorial Hospital and Northwestern University regarding consent to test the Myxo ETlogix prototype heart valve device in unsuspecting patients. The heart devices have caused over 5,000 adverse events, and of those 700 deaths in patients who have received this type of heart device manufactured by Edwards Lifesciences, (Irvine, CA).
From 2006 to 2007, the Myxo ETlogix model 5100 was tested in patients, and study results were published in the leading cardiac surgical journal in the United States, The Journal of Thoracic and Cardiovascular Surgery. Patients were not given informed consent for the testing of the device, and the FDA was never informed of the testing nor the sales of the device until July 2008. The FDA, placed 2 of the medical devices manufactured by on voluntary recall, from October 2008 to April 2009, but still never informed the patients. Ms. Sarah Clark-Lynn of the FDA when asked in an email if the FDA was planning to inform the patients:
“While FDA is not notifying patients, the hospital issued two letters to patients. The first letter was sent on Jan. 26, 2009, and the second on May 8, 2009, after FDA cleared the device. In light of these letters and the subsequent clearance of the device, reflecting FDA's determination that the device meets applicable safety and effectiveness standards, FDA believed that further and direct patient communication may needlessly raise concerns among patients implanted with the device.”
Dean Harrison the CEO of the Northwestern Memorial, who authored the January 26, 2009, referenced by Clark-Lynn, states “that NMH does not consider the Myxo device to be experimental”, but he failed to report to in the letter to the patients that the Myxo and IMR devices were both under a voluntary recall. Despite this statement, the FDA database for adverse events, demonstrates that the annuloplasty product line manufactured, and sold by Edwards Lifesciences has over 5000 adverse events and of these events 700 are deaths, which markedly higher than the annuloplasty rings manufactured by other medical device companies.
Senator Charles Grassley, Ranking Member of the Senate Finance Committee, led an investigation in December 2008. Grassley sent several letters to Northwestern University, Northwestern Memorial Hospital, (Chicago Il,) the Food and Drug Administration, (Rockville, MD) and Edwards Lifesciences (Irvine, CA) requesting answers of these allegations of human experimentations, the lack of informed consent, and marketing without FDA approval. Documents were sent to the Finance Committee and for 4 years the investigation was considered closed until 2014.
In 2014, Senator Grassley discovered internal IRB documents issued by Northwestern University waiving the patients’ rights to know that their clinical test results were used for the eventual FDA approval in 2009. After learning that Northwestern failed to submit documents to the Senate Committee in 2009, Grassley requested the documents and answers to why the documents were missing from the initial inquiry regarding the device. Grassley wrote to Northwestern on March 4, 2014,
“Moreover, the … documents which you belatedly disclosed bear directly on the question that precipitated my investigation in 2008 and remains unanswered: did Northwestern implant an unapproved device — which it knew, or should have known, required approval — in patients without obtaining their informed consent?”