- Posted October 7, 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
Senate Finance Committee Summary of the investigation of Northwestern University, FDA and Edwards Lifesciences
Dr. Patrick McCarthy of Northwestern recently admitted under oath in a malpractice lawsuit that a patient he operated on in 2006 had a heart attack while receiving an investigational heart device called the Myxo 5100. This admission comes amid years of denials from McCarthy, the hospital and Northwestern University about human experimentation during cardiac surgery without consent from patients.
Despite the recent admissions by McCarthy and the hospital, the FDA when asked, does not plan to contact any other patients operated on during the investigational time period.
"In light of these letters [Northwestern sent to patients] and the subsequent clearance of the device, reflecting FDA's determination that the device meets applicable safety and effectiveness standards, (the) FDA believed that further and direct patient communication may needlessly raise concerns among patients implanted with the device," said the FDA.
From 2003 to 2009, patients across the country thought they were receiving FDA approved devices during open heart surgery. However FDA was unaware of the implantations going on in major academic centers, including New York, Chicago, and Cleveland, until Dr. Nalini Rajamannan, the Valve Director at Northwestern brought it to the FDA's attention in 2008. This revelation was discovered when her patient, Antonista Vlahoulis, informed her that she was unaware of the experimental nature of the device.
Three months later, the FDA mandated a voluntary recall pursuant to 21 CFR 7 to remove the Myxo and a second device, the IMR, by the manufacturer Edwards Life Sciences, Irvine CA, from all hospital shelves. Neither the Myxo nor the IMR had FDA clearance between 2003 and 2009.
Since 2008, Northwestern has publicly denied McCarthy's human experiments. These denials are confirmed in a letter sent to the patients during the voluntary recall period by the CEO of Northwestern Memorial Hospital, Dean Harrison, endorsing claims that the device was not experimental. This is the same letter that the FDA is relying upon in 2012 to defend their position. Northwestern failed to comment on the issue when recently contacted.
So far, there are 667 patients with the investigational Myxo device who are still unaware of the surgical experiment. Since 2008, Rajamannan has requested meetings with the University and Hospital to get the proper health care for these patients. These requests have been denied. The Nuremberg and Common Rule laws, adjudicated by the International Tribunal of the Hague, are intended to protect human subjects from unauthorized experimentation.
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