Dr. Rajamannan Holds Meeting With CDRH Ombudsman Abiy Desta to Review New Evidence of Concealment and Injuries Related to the Testing of FDA Investigational Heart Device
"Our responsibility is to do no harm and to protect from harm," says Dr. Rajamannan.
ROCHESTER, Minn., March 9, 2020 (Newswire.com) - Dr. Rajamannan reviews evidence of newly discovered heart attacks missing from the final scientific publication in the AATS and recent disclosures to the Illinois Supreme Court ARDC.
Excerpt from the meeting between FDA CDRH and Dr. Nalini Rajamannan:
“As a Mayo Clinic/NIH trained physician-scientist, chairman of the NIH Working Group for Valvular Heart Disease, and a board-certified Cardiologist, I am gravely concerned. I personally witnessed multiple heart surgery patients being used as human research subjects without their consent.
Thank-you Mr. Desta for accepting the meeting on behalf of the HHS Secretary and the FDA Commissioner who are busy with the fight against the coronavirus in the United States and globally.
I have several new revelations to disclose to you today regarding the research violations, which occurred during the unauthorized testing of heart devices to report to the HHS Secretary and to the FDA Commissioner.
The most important revelation is that another patient has learned he was secretly enrolled in the Myxo Study, suffered a heart attack which was not disclosed for 12 years and the heart attack was not reported to the patient during the hospitalization for the experimental heart surgery.
The heart attack was never published in the outcomes of the clinical trial. The same trial used to eventually clear the device by the FDA with the new name and new indication.
All of this occurred right under the watchful eye of Health and Human Services.
Beginning with my first day of Mayo Medical School – now the Mayo Clinic Alix School of Medicine – I received extensive training in ethics regarding the protection of research subjects and the mandatory requirement to report violations.
As an NIH awardee of the American Recovery and Reinvestment Act, I have lifelong whistleblower protections. And that same ARRA funding is linked to reporting responsibilities under the federal code 46CFR45 and 21CFR820.30.”
“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 are 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
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 and the Model 4100.
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.
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Source: Most Sacred Heart of Jesus Cardiology and Valvular Institute
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