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Saturday, September 30, 2023

Letter to the Editor: Chancellor Blank will need to address health care fraud, cover-up by Northwestern University

On October 14, 2021, Mackenzie Moore wrote an article entitled, "Bucky Catches Chancellor Becky Blank with Willie the Wildcat, asks for amicable separation."

This article may very well be prophetic as Chancellor Becky Blank will assume and be confronted with, as future President for the Northwestern University, an issue of federal non-compliance which injured numerous patients without their consent at Northwestern Memorial Hospital, the hospital for Northwestern University’s Medical School.

This issue goes back to 2006 and involves cardiac surgeon Patrick McCarthy and device-maker Edwards Lifesciences. Heart rings, lacking the required FDA device clearance, were implanted in patients' hearts without their consent.

The issue has now morphed into a legal matter with a motion pending before the Illinois Supreme Court. Under the rules of Professional Conduct 8.3 and 8.4, the Supreme Court Judges, the Illinois State Bar and the Attorneys licensed in the State of Illinois are responsible for the truth.

We are three patients from over 1000+ patients who had heart rings implanted without our prior informed consent. We underwent illegal human surgical experiments, i.e., the heart ring implants, which damaged our hearts. This was done without our consent and without FDA authorization.

FDA authorization for medications, vaccines and medical devices is a federal requirement for use in patients across this country. Northwestern University delayed reporting to the FDA the fact that Northwestern University began the secret human clinical trials to test patent-pending inventions once the new chief of Cardiac Surgery, Dr. Patrick McCarthy, arrived from the Cleveland Clinic after facing similar failure to report to patients testing and conflicts of interest as published in the Wall Street Journal, while several years later the same company faced a Department of Justice indictment in Ohio for Medicare fraud.

The Vice President for Research Ann Adams, who is charged with protecting patients, and the Chief General Counsel for Northwestern University Stephanie Graham have delayed reporting the evidence that non-approved heart devices were tested in over 1000 patients' hearts. Again, FDA never authorized the testing in the patients; moreover, FDA only learned of this issue when the results were published in The Journal of Thoracic and Cardiovascular Surgery in 2008 and again in 2020, waiving our rights to know he was experimenting on us when we went for surgery, A. Edwards, M. Obermeier and A. Vlahoulis. We were never informed that this surgeon was testing his experimental devices and protocols, all of which failed during our heart surgeries.

The Motion is now pending in the Illinois Supreme Court to help get the information to patients who were tested from 2006-2020, confirming that the university has had knowledge that the devices tested in our hearts were classified as investigational since 2009, once the FDA learned that the human experiments were ongoing at Northwestern University since 2004.

A doctor from Wisconsin has been advocating for over 14 years after witnessing the experimental surgeries and informing the General Counsel for Northwestern University, two presidents for Northwestern University, the United States Senate, Wisconsin Elected officials and Northwestern University’s Board of Trustees, as covered by Wisconsin’s own NBC26, Green Bay, Wisconsin.

The Supreme Court Motion summary and evidence was posted in a published press release on September 21, 2021.

More than 1,000 patients who underwent experimental heart surgeries without their consent and without FDA authorization finally may get justice.

The Illinois Supreme Court accepted a motion on Sept. 17, 2021 that would compel the Illinois Attorney Registration and Disciplinary Commission to submit life-saving medical evidence to Northwestern University's general counsel. That, in turn, would require the university's human subject research protections program to inform those patients.

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Northwestern University attorney Stephanie Graham and Ann Adams, Vice President for Research, have stated that the "Myxo Ring" heart device was "FDA approved" since 2004. The device manufacturer's attorney David Jensen of Eichorn and Eichorn, however, stated the second version of the Edwards Lifesciences device was not approved until April 2009. There is no FDA approval, on the record, for the first version of the device.

Transferring that evidence to Northwestern University would start the 14-year process of informing the hundreds of patients who never were informed of the investigational nature of the device and the experimental heart surgery, under the federal reporting regulations 45CFR46 and 21CFR50.

Dr. Nalini Rajamannan, a Mayo Clinic Trained Cardiologist who now practices in Sheboygan, Wisconsin after years as a faculty member at Northwestern University and VA Hospitals in Chicago, has been advocating on behalf of these patients, who are unaware that they received FDA unapproved devices. Since 2006, more than 1000 patients have undergone the experimental heart surgery without consent. The Daily Northwestern newspaper reported on one patient's death in 2018. Other publications have reported over the years on other patients' complications. But the full scope of harm can't be documented until all patients are made aware of the issue. Figure 1, the Investigational "Myxo ring," Figure 2, the second version, the Detlogix ring approved by the FDA in April 2009.

In reviewing his own health records in 2018, Dr. S. Albert Edwards discovered he had had a heart attack 11 years earlier, in February 2007, at the conclusion of his heart ring implant and had not been told. "I requested more information from the university office of human subject protections and I received the following letter stating, 'we consider this matter closed.'"

In the scientific article regarding the experimental heart surgeries published in the Journal of Thoracic and Cardiovascular Surgery by the American Association of Thoracic Surgeons, the authors confirmed that patients waived their "patients' rights to know" regarding the study they were enrolled in as of November 2020.

The FDA requested that Northwestern University retroactively inform patients — dating back to Nov. 2008—that their registry data was used to publish the initial "first in human testing" of the Myxo Ring. Instead of reporting the testing, Northwestern Hospital's president and CEO Dean Harrison in Jan. 2009 sent a letter to patient Edwards and other patients who had received the Myxo ring. It stated that "we do not consider this device to be experimental."

This information was published by the Chicago Tribune in May 2011. In the same story, Dr. Jeff Shuren, head of FDA medical device branch, confirmed the opposite, saying, "If a device is supposed to get cleared by the agency first before you're marketing it, we consider that investigational."

As of today, the patients have not been informed. The Illinois Supreme Court now has jurisdiction over this process.

Chancellor Blank may very well need Bucky's support sooner than later to unpack a 14-year health care fraud and cover-up perpetuated by Northwestern University.

This letter has been edited for clarity.

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