- Posted October 16, 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 Chronicle of Higher Education, Myxo Files, Cook County Court Records Documents the Heart Attack
Northwestern University Ethics Review Approved Testing of Medical Devices in patients without informed consent
Cook County records are in the Public Domain.
The chornicle of Higher education has provided permission to reproduce the Chronicle story for the Myxo Files to Dr. Rajamannan,
ECG and Ring images used with permission from the patient and published in the Myxo File Part VII: The Design History File The Smoking Gun
In October 2011, the Chronicle of Higher Education documented the events of the Tenure Denial and termination of Dr. Rajamannan after renewal of the ARRA and NIH grants for 2011 -2012.
The author documented the evidence and found the missing heart attack that was not listed in the clinical study nor the FDA compliance review as documented in the letter to the honorable Senator Lugar.
The heart attack and the cook county records are posted on this site, excerpts from the article published on the article of higher education..
“Northwestern University has fired an accomplished heart doctor after she produced evidence suggesting its chief of cardiac surgery won federal approval of an implant invention by making a false claim about its safety.
The dismissal late last month of Nalini M. Rajamannan, an associate professor of medicine, is the most drastic step to date in a four-year battle by Northwestern to defend the cardiac surgeon, Patrick M. McCarthy, against accusations in two lawsuits that he experimented on patients without their knowledge and hid evidence to help his device win a safety approval.”
“Northwestern had already stripped Dr. Rajamannan of her clinical privileges and denied her tenure. It finally removed her on September 30, even though she still has federal research grant money, after she reported having discovered a record of a patient's electrocardiogram that appeared to undercut Dr. McCarthy's key published assertion that no recipients of his invention had suffered a heart attack.
"When I brought the EKG data to them," Dr. Rajamannan said, "they fired me."”
“A spokesman for Northwestern, however, says that there was no retaliation against Dr. Rajamannan and that her dismissal was a straightforward result of the fact that she was denied tenure. "She was under consideration for tenure, and the customary and clearly defined procedures, including peer review, were followed," said Alan K. Cubbage, Northwestern's vice president for university relations. "There was no retaliation by Northwestern University against Dr. Rajamannan."”
“…the two lawsuits, filed by patients of hers, suggest that Dr. McCarthy, a star in his field worth millions of dollars to his university, may have worked with Edwards to routinely test innovations on unsuspecting human subjects.”
“The Myxo ring is one of several close variants of another ring device that had already won FDA approval, and thousands of patients have had a Myxo ring or one of the other variants sewn into their hearts since 2000. Dr. Rajamannan contends those implants have been associated with more than 4,000 adverse outcomes, including more than 600 deaths—a sharply higher figure than the several hundred negative outcomes associated with the FDA-approved ring.”
“…A spokeswoman for Edwards Lifesciences, Sarah Huoh, said the company had made a good-faith attempt to apply the authority the FDA gives companies to assess whether a device is significantly similar to an existing approved device. "Occasionally, the FDA reviews a manufacturer's decision and disagrees, and this is what took place," Ms. Huoh said.”
“The dispute led Edwards Lifesciences to seek specific approval of the Myxo ring and another similar device it manufactures. Dr. McCarthy led the ensuing safety study. His findings, published in 2008 by The Journal of Thoracic and Cardiovascular Surgery, reported that he had implanted the Myxo ring in 100 patients with no significant problems, including no heart attacks. The FDA, citing that study, granted its approval of the Myxo ring.”
“But another patient of Dr. Rajamannan, Maureen Obermeier, also filed suit, claiming her heart-valve condition also worsened after she received the Myxo ring in a surgery performed by Dr. McCarthy. Ms. Obermeier's lawyer asked the hospital for her medical records, and was given a set with no documentation of an electrocardiogram from the day of her implant surgery in November 2006. The hospital later produced the electrocardiogram results, showing an apparent heart attack in the hour after Ms. Obermeier's surgery, but it did so only after Dr. Rajamannan combed through Ms. Obermeier's files and discovered she had been billed for the test. And then, in an affidavit for the Obermeier lawsuit submitted just two months ago, Dr. McCarthy acknowledged that the electrocardiogram showed Ms. Obermeier had suffered a heart attack shortly after the surgery.”
Dr. McCarthy, in a written response to questions from The Chronicle, said some patients given the Myxo ring were excluded from his study's summary of results because they had other medical conditions that could have caused a heart attack. Although that condition of the study was not noted in the journal article's summary, the article does describe the exclusion of patients with conditions that include rheumatic valve disease. And Ms. Obermeier's records show she had a childhood history of rheumatic fever.”
“But, Dr. Rajamannan said in an interview, if Ms. Obermeier's rheumatic scarring made her ineligible for consideration in the study, she should have also been ineligible for the Myxo ring. "If he thinks that she had rheumatic-valve disease, then she never met criteria from the moment he opened up her chest wall," she said. There is an existing FDA-approved ring for patients with that combination of conditions, she said.”
By Paul Basken
Chronicle of Higher Education