- Posted October 18, 2013 by
- 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
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- 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
In 2013: US Citizens who go for open heart surgery, may receive non-FDA approved devices
Northwestern University Research Integrity Review Approved Testing of Medical Devices in patients without informed consent: Fraudulent Inducment
Patients who go for open heart surgery, may receive non-approved FDA heart devices. The FDA is not planning on reporting to the patients if the devices are experimental. Thousands of patients have suffered and over 650 patients have died across the USA who have this line of annuloplasty devices in their hearts according to the MAUDE database.
The purpose of this story is to report the non-approved tests 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, including the heart attack as reported in the Myxo File PArt VII and the CNN report.
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.
As a doctor and a former researcher at Northwestern, I am especially concerned about public and private funding of research at Northwestern if this misconduct is not addressed properly. Nevertheless, Northwestern has taken no serious action to address these research improprieties. Instead, Northwestern has retaliated against me for my reports of research misconduct.
In July 2008, Dr. McCarthy reported results of his non-FDA approved, non-IRB approved and unregistered clinical trial in the Journal of Thoracic and Cardiovascular Surgery, Volume 136, Number 1, July 2008. The report included Ms. Vlahoulis’ medical data without her consent. The report falsely claimed that the Myxo ring was FDA-approved and IRB-approved, and that the participants consented to the clinical trial. However, when Ms. Vlahoulis inquired with the FDA in July 2008, the FDA responded that it had no information regarding the Myxo ring; the FDA was unaware that the Myxo ring even existed.
Quick, simple investigation by the Northwestern ORI would have revealed that the Myxo ring was not FDA-approved and not IRB-approved, and that the clinical trial was not IRB approved and was not registered with HHS.
In September 2008, Ms. Vlahoulis reported to Northwestern’s Office of Research Integrity that the Myxo ring had been implanted in her heart without her consent, and reported that the Myxo ring was neither FDA-approved nor IRB-approved. However, Dr. Don Workman, executive director of the ORI, and Ms. Ann Adams VP for Research and head of the ORI for Northwestern University, misrepresented to her that the Myxo ring was FDA approved.
To Date: There are thousands of non-approved annuloplasty devices in patients implanted between 2003-2009 and these patients have no knowledge that these devices are classified as investigational in the internal FDA databases.
Evidence as Documented in CNN ireporter:NRajamannan