CHICAGO, Sept. 11, 2012 /CNW/ - 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
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.
SOURCE: Rob Amaefule
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