- Posted March 7, 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
Heartwire Reports: Myxo Ring Controversy Reopened with New Questions From Sen Grassley
"By: Shelley Wood
March 06, 2014
Northwestern Memorial Hospital, citing "several inadequacies" in past responses to his efforts to understand how the annuloplasty ring was first used, prior to FDA clearance.
It was a heartwire story in 2008, chronicling Northwestern surgeon Dr Patrick McCarthy's use of the annuloplasty ring he'd invented prior to its formal FDA approval, that first prompted Grassley to investigate the Myxo ring. In 2009, Grassley followed up with a letter to the FDA, addressing the agency's handling of the ring's path to regulatory clearance. Then, in 2010, Grassley zeroed in on the 510(k) loophole that had allowed the Myxo ring to be cleared—under a new name (the ETlogix)—after being used in patients at Northwestern. Questions about this regulatory pathway have spurred the FDA to recommend changes to its 510(k) process.
Now, four years later, Grassley's latest letter to Northwestern University and its affiliated hospital states that the senator has received new information, prompting him to reopen his line of questioning. The letter notes that McCarthy, the device inventor, "made contradictory statements" regarding the similarity of the Myxo ring to already-approved devices. Grassley also cites uncertainty over whether patients were sufficiently informed about safety issues regarding the use of the device at Northwestern Memorial Hospital.
The Myxo ring was cleared rapidly by the FDA shortly after heartwire 's investigation in 2008, but by that point had already been in use for two and a half years. The device was cleared under rules that deemed its design and purpose were similar enough to already-approved products, meaning it didn’t need its own 510(k) premarket notification. This was despite published papers touting the ring’s unique suitability to treating myxomatous disease.
Grassley's letter points to documents he believes were withheld back in 2008, when he requested access to all internal correspondence regarding the Myxo ring.
A protocol application signed by McCarthy.
An echo protocol authored by McCarthy.
A waiver-of-consent form signed by McCarthy.
A letter dated June 29, 2006 addressed to McCarthy indicating institutional review board (IRB) approval for a one-year period between June 29, 2006 and June 27, 2007.
A HIPAA waiver-of-authorization form addressed to McCarthy from the university's IRB.
These documents, writes Grassley, came to his attention via Dr Nalini Rajamannan, the whistle-blower and former Northwestern physician who first raised concerns about the device use at Northwestern.
Rajamannan confirmed for heartwire that she was able to obtain the documents from the Cook County Circuit Court when they became part of the public docket in one patient's litigation against Edwards Lifesciences, Northwestern Memorial Hospital, Northwestern Memorial Faculty Foundation, and McCarthy.
The documents "fall squarely within the scope of my December 3, 2008 letter," Grassley writes, adding that he is now requesting copies of all of these documents, plus any other documentation relating to the particular IRB project number that these documents relate to.
McCarthy and Northwestern have long claimed that patient informed consent was obtained for the early use of the device or was not required because they believed on the basis of assurances from the manufacturer that the device was FDA-cleared. News of a waiver of consent hints that the patient may not have explicitly known that study results were intended for publication. Indeed, the first patient to come forward with concerns about her Myxo ring procedure told heartwire back in 2008 that she never agreed to be a part of a study of the Myxo ring specifically, although she signed consent forms agreeing to be part of an atrial-fibrillation database as well a heart-valve biology study.
Asked about the latest Grassley letter, Alan Cubbage, vice president for university relations at Northwestern University, said only that "the university will look into the issues raised and respond to Senator Grassley."
"See also: The Myxo ring mix-up