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April 3, 2014 Iowa senator's request revives controversy over medical device used at Northwestern
"Iowa senator's request revives controversy over medical device used at Northwestern
Cat Zakrzewski, Reporter
April 3, 2014 •
A U.S. senator is analyzing new documents he requested from Northwestern related to a 2008 controversy over a medical device patients alleged was used before it was cleared by the Food and Drug Administration, a spokeswoman told The Daily on Wednesday.
Iowa Sen. Chuck Grassley, the top Republican on the Senate Judiciary Committee, wrote “several inadequacies” existed in reports NU provided the committee in 2008 and 2009 about an annuloplasty ring implanted at Northwestern Memorial Hospital. In 2007, Dr. Nalini Rajamannan, a former NU professor and cardiologist, accused her colleague Dr. Patrick McCarthy of implanting a ring, formerly called the Myxo ring, that did not yet have FDA approval in patients without consent.
"The study should have stopped and informed consent given to patients," Rajamannan, who once worked on the study with McCarthy, wrote in an email to The Daily. "(I'm) trying to protect the patients and to protect the integrity of Northwestern University from unauthorized human experimentation during open heart surgery."
Rajamannan's employment was terminated at NU in September 2011. The next month, she told The Daily she thought her tenure was denied due to whistleblowing in the Myxo ring experiment. At the time, University spokesman Al Cubbage would not comment on the reasons Rajamannan was denied tenure.
Grassley’s request for more information from NU came after Rajamannan told the senator NU withheld a series of documents related to the senator’s 2008 and 2009 requests, including a waiver of consent form, according to a letter he addressed to University President Morton Schapiro and Northwestern Memorial Hospital president Richard Gannotta.
Rajamannan said she found the waiver in February in Cook County court documents. She said she then informed the Judiciary Committee, the Northwestern Institutional Review Board and NU's Board of Trustees of her findings.
Grassley's letter also says McCarthy has made “contradictory statements” about the Myxo ring and preexisting devices. He also said it is unclear if patients “received sufficient notice of the safety questions that arose” regarding the ring.
McCarthy invented the ring, which was similar to one already cleared for use by the FDA. NMH spokeswoman Holli Salls told The Daily in 2011 the updated ring was commercially available at the time of the procedure and was in turn thought to be approved by the FDA. Salls said the FDA later told the manufacturer the updated ring should have undergone a more rigorous FDA approval process.
In April 2009, the device was cleared under the new name dETlogix Annuloplasty Ring.
Cubbage said NU submitted the documents the senator requested by the March 14 deadline he set. He would not release a copy of the report the University provided to Grassley because he said it contained “confidential” information. Jill Gerber, Grassley’s spokeswoman, said the senator plans to release the documents.
Cubbage declined to comment on the Grassley’s assertion NU withheld key documents when the committee investigated the Myxo case in 2008 and 2009.
Gerber said the senator plans to release a response to NU soon but could not provide a specific timeline.
Editor's Note: This story has been updated to clarify the timeline by which Rajamannan informed Northwestern of her findings."