- Posted October 6, 2013 by
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Northwestern University and major Heart Valve manufacturer are the Center of the Myxo Cover-Up
CHICAGO, IL, Sept. 25, 2012 /PRNewswire/ - The Myxo Etiologix model 5100, also known as the Myxo 5100 is a heart
valve device manufactured and introduced to the market by Edwards LifeSciences (Irvine CA) in 2007. This device was
specifically designed to treat the Myxo disease, an illness that causes a leaky heart valve. Despite being sold and surgically
implanted into patients in the US market since 2007, it appears as if the Food and Drug Administration who approves the
marketing of all medical devices, was unaware that the Myxo 5100 was on the shelves. In fact, Edwards failed to apply for an
investigational device exemption for the Myxo 5100 which is required under FDA law 21 CFR 812.2 in 2006 when the first
prototype models were made for human experiments. Northwestern also failed to obtain informed consent from patients
which violate the Common Rule 45 CFR 46 which is a requirement in this country.
According to the Public Pair Patent website, Edwards LifeSciences applied for a patent on the device from 2004-2007,
which included several claims modifying the shape in order to demonstrate a unique invention. Subsequently these changes
resulted in new patent awarded by the United States patent office in 2007. Simultaneously, Edwards claimed in their own
internal documents which are termed a justification to file, in 2006, documenting the Myxo device as only a minor
modification of the previous device, Geoform Model 4200.
Meanwhile Dr. McCarthy of Northwestern Memorial Hospital tested the Myxo device during its clinical trial between 2006
and 2007. Despite this, the manufacturer neglected to tell the FDA that a new device was tested for the first time in humans.
In addition, Northwestern and McCarthy neglected to tell the patients using full informed consent, as stated to the Senate
Finance Committee in 2010. This human experiment was unlawfully done without informed consent and without FDA
knowledge, despite Dr. Nalini Rajamannan the Valve Director at Northwestern University attempts to bring the human
clinical trial to the attention of Northwestern University Dean's office and the Board of Trustees, the FDA, Health and
Human Services(HHS) and the National Institute of Health(NIH). In October 2008, FDA initiated a voluntary recall
pursuant to 21CFR7 and cleared the device with a new name in April 2009.
On July 16, 2009, the congressional liaison from the FDA wrote a letter to patient Antonista Vlahoulis deeming the Myxo
device investigational. The letter also stated Senator Richard Durbin would contact her regarding the investigational status.
Vlahoulis claims to not have received any form of contact from the Illinois Senator to date. When recently contacted,
Senator Durbin's office failed to comment on the issue.
In 2008, Senator Charles Grassley of Iowa initiated a Senate Finance Investigation by sending several Congressional letters
to Northwestern, Edwards and the FDA. This investigation appears to have gone stagnant since 2010, the last time in which
any updated information was released.
When contacted, Senator Grassley's aid mentioned that "competing interests" are preventing them from commenting.
The fact that a company could invent a new device then test it for the first time in humans without telling anyone raises
questions. The FDA admits that Edwards marketed the device without the necessary 510k clearance. Despite this, they still
cleared the predicate device the dETlogix model 5100 and a second device, the IMR model 4100.