NEWS PROVIDED BY
Candelaria Productions
Aug. 15, 2022
CHICAGO, Aug. 15, 2022 /Christian Newswire/ -- University of Michigan officials are questioning whether a well-known cardiac surgeon should be leading a large-scale study on a new heart device.
The uncertainty stems from whether the doctor is in compliance with federal, state and local rules surrounding an unrelated study from 2006. The crux of the controversy is that the Northwestern University cardiac surgeon never informed patients that the study was experimental nor that the device was one that he helped develop.
The Myxo version of the device had not been approved by the FDA, and considered investigational since 2009, after a voluntary recall, as confirmed by the FDA Congressional office, to Senator Charles Grassley. And to date, as of FDA regulatory decision, requiring all 1000 patients be informed, as per the FDA media affairs office on January 3, 2022. Those patients still haven't been informed that experimental medical devices were implanted using a protocol which the university terminated back in 2007, was performed without their knowledge, even though some patients have suffered adverse effects and/or died.
Now Dr. Patrick McCarthy is leading another large-scale study and enrolling patients in a second study that spans institutions across the United States including the University of Michigan, Harvard, Duke, Mayo Clinic, Kansas University Medical Center, Abbott Northwestern Hospital Minn., Henry Ford Hospital Detroit, University of Pittsburgh, Cedars-Sinai Medical Center, Stanford Medical Center, Scripps Health, St. Vincent Hospital Indianapolis, and NYU Lagone.
President Coleman from University of Michigan's office confirmed via the University of Michigan public affairs office that they are "still looking into the matter" as of August 12, 2022, as per the email dated August 1, 2022:
"Thank you for taking the time to write to the Office of the President and other officials at the University of Michigan. I can confirm receipt of your messages, which have been passed on to the appropriate parties. They are looking into this situation."
Several former patients are cheering Michigan's investigation, saying McCarthy shouldn't be allowed to lead another heart valve or atrial fibrillation surgical study until every patient from his previous study is officially informed that the device they received hadn't been FDA approved. Several patients have contacted President Coleman's office and the Chicago FBI's field office, with the federal evidence of non-compliance.
Dr. Albert Edwards, a University of Michigan graduate never signed up for the heart valve experiment. A 2011 letter from Northwestern University's IRB confirmed that there was no informed consent.
Peter Pitts, of CMPI, and former associate commissioner for the FDA has reviewed the inspection documents and comments on the FDA inspection delays as he did for the delays for the baby formula to rectify outstanding FDA regulatory decisions:
"The question is not clinical effectiveness. The question is whether this investigator is in regulatory compliance."
The company changed the name of the device and the indication. Yet as of today, the myxo version is still investigational as of July 2009.
"If a device is supposed to get cleared by the agency first before you're marketing it, we consider that investigational," Dr. Jeffrey Shuren, head of the FDA's medical device branch, told the Chicago Tribune."
SOURCE Candelaria Productions
CONTACT: Oscar Delgado, 773-573-6890, [email protected]
