- Posted October 6, 2013 by
This iReport is part of an assignment:
Shutdown over: What next?
- MORGAN LEWIS RESPONSE TO THE SENATE FINANCE COMMITTEE CONFIRMING THE FACT THAT THE OUTCOMES REGISTRY HAD NOTHING TO DO WITH THE MYXO ETLOGIX CLINICAL TRIAL
- 150 years later, newspaper retracts editorial panning Gettysburg Address
- OHRP FDA REGULATIONS FOR INFORMED CONSENT CLASSIFIES INVESTIGATIONAL DEVICES SUCH AS THE MYXO ETLOGIX MODEL 5100 UNDER THE LAWS WHICH REQUIRE FULL INFORMED CONSENT:
- FDA CONGRESSIONAL OFFICE ON JULY 16, 2009 OFFICIALLY CATAGORIZES THE MYXO ETLOGIX MODEL 5100, MANUFACTURED BY EDWARDS LIFESCIENCES AS INVESTIGATIONAL AND OF SIGNIFICANT RISK
- Northwestern University and Northwestern Memorial Hospital Elements of Informed Consent : HIPPA WAIVER DOES NOT APPLY TO FDA STUDIES subject to the FDA regulations at 21 CFR 50
The President of The United States: Stop Implantation of non-FDA approved heart devices in US citizens
Link to sign the petition:
The President of the United States
The U.S. Senate
The U.S. House of Representatives
The Governor of IL
The IL State Senate
The IL State House
The President of The United States, The White house
President Morton Schapiro, CEO Northwestern University
Mr. Patrick Ryan, Board of Trustees Northwestern University
Mr. Neil Bluhm, Board of Trustees Northwestern and Bluhm Cardiovascular Institute
Ms. McPhilimy, Audit Office for the Board of Trustees Northwestern University
Dr. Margaret Hamburg, FDA
Dr. Jeffrey Shuren, Director for CDRH FDA
Dr. Kathleen Sebelius, Director of HHS
Dr. Francis Collins, Director for the National Institute of Health
Nalini M. Rajamannan, MD, Sacred Heart Cardiology
Ms. Sarah Fitzpatrick, CBS evening News
Mr. Dan Cantrall, Senior Aide to Congressman Daniel Davis of the 7th District
Senator John McCain, Office of Senator John McCain
Ms. Binta Beard, Health Care Aide for Senator Durbin
Ms. Erika Smith, Senator Grassley's Aide on the Senate Judiciary Committee
Mr. Rob Amaefule, Independent Journalist
Mr. Thomas Friedman, New York Times Washington Bureau
Mr. Scott Pelley, CBS News New York
Mr. Armen Keteyian, CBS Investigative Reporter
My name is Dr. Nalini M. Rajamannan, M.D. I am a Cardiologist at Sacred Heart Cardiology. I was the Valve Director of the Bluhm Cardiovascular Institute and formerly an Associate Professor at the Northwestern University Feinberg School of Medicine. I had NIH R01 and ARRA funding up until September 30, 2011.
I had a research practice at Northwestern University since 2000, and I had a clinical practice at Northwestern Memorial Hospital from 2000 until October 2008. I also had a clinical practice at the Veterans Administration Hospital for many years. Before coming to Northwestern, I had a research and clinical practice at the Mayo Clinic for 14 years after graduating from medical school at Mayo.
I attended the University of Notre Dame, South Bend IN before medical school.
The purpose of this petition is to report research misconduct at Northwestern University and Northwestern Memorial Hospital involving an unregistered and unapproved clinical trial of a non- FDA approved medical device. The device was known first as “The McCarthy Annuloplasty Ring,” then as the “Myxo-ETlogix annuloplasty ring,” and now as the “dET-logix annuloplasty ring.”
I have repeatedly reported the research and medical misconduct to officials at the Northwestern-affiliated institutions, but to no avail. I have been retaliated against as a result of my reports of research and medical misconduct at Northwestern. I have reported these events from the Dean’s office of the Medical School to the Board of Trustees including the CEO for Northwestern University.
Medical research at all Northwestern-affiliated entities is governed by federal and state mandates, and by research guidelines and mandates of Northwestern University. Northwestern researchers and medical professionals are required to report medical and research misconduct. Reporters of research misconduct are supposed to be protected from retaliation. The relevant Northwestern policies and mandates are located at www.research.northwestern.edu/oprs/.
On April 26, 2006, a now-former patient of mine, Antonitsa Vlahoulis, underwent open-heart surgery at Northwestern Memorial Hospital. During the surgery, a mitral valve repair was performed and a Myxo-ETlogix annuloplasty ring was implanted in the mitral valve of Ms. Vlahoulis’ heart. The surgery was performed by Dr. Patrick McCarthy, M.D., a Northwestern cardiothoracic surgeon. Dr.
McCarthy invented the Myxo ring, which was described as the “McCarthy Annuloplasty Ring” at that time. Dr. McCarthy received a royalty for the ring he implanted in Ms. Vlahoulis’ heart. Dr. McCarthy had previously assigned the patent for the Myxo ring to Edwards Lifesciences, LLC, the
manufacturer of the Myxo ring. Edwards paid the royalty to Dr. McCarthy, and paid him consulting fees.
The Myxo ring did not have FDA approval or IRB approval. Edwards (manufacturer of the ring) never submitted anything to the FDA for approval of the Myxo ring for 2½ years, until October 2008. Northwestern (where the Myxo ring was implanted in patients without their consent) never submitted anything to the FDA or to Northwestern’s IRB for approval of the Myxo ring. Dr. McCarthy(the inventor of the Myxo ring who implanted the ring into patients’ hearts at Northwestern without their consent) never submitted anything to the FDA or to Northwestern’s IRB for approval of the Myxo ring. Northwestern, Edwards and McCarthy never applied to the FDA for an Investigational Device Exception (“IDE”) for the Myxo ring. Nevertheless, Edwards marketed the non-FDA
approved Myxo ring for 2½ years and McCarthy implanted the ring in patients’ hearts for 2½ years to treat their myxomatous heart valve disease.
The clinical trial of the Myxo ring conducted at Northwestern was not registered with the Department of Health and Human Services as mandated by federal law; nor did it have IRB approval from Northwestern as mandated by federal law and Northwestern’s IRB rules. In fact, Edwards, Northwestern entities and Dr. McCarthy never submitted anything to obtain approval from
Northwestern’s IRB for the clinical trial of the Myxo ring. Data from the unregistered and unapproved clinical trial was manipulated, and data of adverse events involving the Myxo ring was omitted and suppressed.
In May 2007, I discovered that Ms. Vlahoulis had not consented to be implanted with a Myxo ring, but rather had been led to believe that one of several other devices would be implanted in her heart. Ms. Vlahoulis was not informed that Dr. McCarthy invented the device that was inserted in her heart,
and was not informed that he would receive a royalty for the device. Dr. McCarthy did not report his financial interest in and conflicts of interest with respect to the Myxo ring as mandated by Northwestern University regulations. In addition, Ms. Vlahoulis was included as a participant in a clinical trial of the Myxo ring without her consent. Eventually, because of damage to her heart caused by the Myxo ring, Ms. Vlahoulis underwent a second surgery at The Cleveland Clinic to have
the Myxo ring removed and replaced with a mechanical valve. She then also had to be implanted with a permanent pacemaker. She may require more surgeries, and possibly a heart transplant. The clinical trial of the Myxo ring at Northwestern was governed by Northwestern’s research policies and mandates.
After I investigated Ms. Vlahoulis’ claims and confirmed the research
misconduct in the clinical trial, I reported the misconduct in July 2007 as mandated by Northwestern’s policies and procedures. I initially reported my findings to Dr. McCarthy the principle investigator on the study and Dr. Robert Bonow, then-Chief of Cardiology and Senior author on the clinical study, but no action was taken. I then reported the matter to the Dean of the Feinberg School of Medicine, Dean Larry Jameson, who is now the Dean of University of Pennsylvania’s medical school and to the Northwestern Medical Faculty
Foundation’s in-house legal counsel, Julia Lynch and Denae Prousis.
I have also reported the misconduct to the Provost’s Office at Northwestern University. Initially, I had been a co-author of the clinical trial of the Myxo ring. Ultimately, I removed my name from the manuscript when I discovered the research and medical misconduct involving the Myxo ring. I have continued to report the misconduct to officials at the Northwestern-affiliated institutions, but to no avail.
I thought that my compliance with Northwestern mandates to report research misconduct would result in Northwestern’s correction of the problem. I thought that Northwestern would welcome assistance to rectify the problems, protect Northwestern’s reputation, comply with governmental laws and regulations, and avoid imperiling research funding at Northwestern.