Press Release (ePRNews.com) - SHEBOYGAN, Wis. - May 22, 2020 - Most Sacred Heart of Jesus Cardiology and Valvular Institute Director Dr. Nalini Rajamannan, has submitted evidence in an open letter to Northwestern University’s Newly Minted Vice President for Research Dr. Milan Mrksich, the Senate Finance Committee, the Senate Committee on Homeland Security, the FDA and the NIH providing the evidence of Non-Compliance of the Federal Insurance policy to protect human subjects as it relates to human subject research over the past 14 years including the current clinical trial: Adaptive COVID-19 Treatment Trial: NCT04280705.
The COVID-19 Letter is online on Amazon.com (The Myxo Files XXXVI: Covid-19 The Letter):
Dr. Rajamannan is an NIH awardee of the American Recovery and Reinvestment Act, after witnessing the events listed in the letter, she continues her lifelong federal reporting responsibilities under the ARRA funding including the federal code regulations: 46CFR45 and 21CFR50, and 21CFR820.30 to ensure that Northwestern University/ the FDA and the NIH are aware of the non-compliance.
“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 in 2011.
The list of violations is as follows:
- Testing of the Model 5100 without consent and without an IDE
- Failure to report the change in the status of the device to the patients by the University’s IRB
- Failure to follow-up on the ongoing harm by the University including deaths, heart attacks and reoperations
- Failure to reveal to the patients and their physicians the experimental status of the device for future long-term testing
- Failure to review the 122 product defects discovered in the prototype version of the device placed in the patients during the experimental surgical testing surgeries.
- Concealment of the correct status of the device to the ARDC of the Illinois Supreme Court
- Delays in placing the cardiac surgical registry on hold until the patients are fully informed of the experimental heart surgeries
- New Evidence of concealment by Northwestern University IRB Chairman
The patients and the physicians await the FDA’s decision to inform the nearly 1000+ patients who unknowingly received the recalled devices the Model 5100, the Model 1155, and the Model 4100.
Request for comment from Northwestern University media affairs office regarding the open letter to the Vice President, resulted in no response to comment on the open letter to the Vice President.
Dr. Nalini Rajamannan is a heart valve expert in the field of cardiovascular medicine. She earned her undergraduate science pre-professional degree from the University of Notre Dame, her Medical Doctorate from Mayo Medical School and her post-graduate training in Internal Medicine and Cardiology at the Mayo Clinic and Research Fellowship on the NIH training Grant. She also worked at the Mayo Clinic as a staff consultant in Internal Medicine and an Associate Professor of Medicine at Northwestern University and the Lakeside and Westside VA. Currently, she practices consultative valvular medicine and Osteocardiology at Most Sacred Heart of Jesus Cardiology and Valvular Institute, WI.
Nalini M. Rajamannan
Medical Director for Most Sacred Heart of Jesus Cardiology and Valvular Institute
Most Sacred Heart of Jesus Cardiology and Valvular Institute