- Posted October 6, 2013 by
- FDA Issues Warning Letter to Edwards Lifesciences, for misbranding of Myxo ETlogix annuloplasty Ring
- Northwestern University 5pm ET Deadline Today to Respond to Senate Judiciary Committee Inquiry Regarding Unauthorized Human Experimentation
- Grassley not satisfied with the responses, continues to press the issue
- Medical Institutions Identified in Secret Testing in Senate Investigation FDA not Responding: Part I
- Part II: Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
Northwestern University performs Human experiments with non-FDA approved Devices
Why would a bright and promising cardiologist be fired from the University hospital that she had practiced at since 2000?
Apparently, protecting her patients is grounds for dismissal. At least, that is the case at Northwestern University in Illinois.
Despite being promoted to Valve Director in 2006, Dr. Nalini M. Rajamannan was terminated in 2008 after reporting the use of non-FDA approved, experimental medical devices being implanted in patients without their knowledge.
The doctor conducting these human experiments, Dr. Patrick McCarthy, was testing his own inventions, an IMR annuloplasty device and a Myxo annuloplasty device manufactured by Edwards Lifescience.
These devices had not been approved by the FDA and even now, many patients have no idea that they have these experimental devices in their bodies.
One Patient's Experience
Dr. Rajamannan first discovered this deception in July 2007 when one of her patients, Antonitsa Vlahoulis, required a second surgery to replace the Myxo annuloplasty device less than a year after it was implanted.
Ms. Vlahoulis questioned why the device she had was not the one listed on her pre-op brochure.
Discussing her experience, Ms. Vlahoulis stated:
"When I had my consult with Dr. McCarthy, he told me that I had severe Mitral valve prolapse. He said with the severity of my valve, he would most likely have to replace the valve with a pig valve or prosthetic. He explained the difference between the two. He also stated that his specialty was saving the valve by repairing it with a mitral valve ring. He never mentioned what type of ring, or that he was an inventor and he had designed a ring for this purpose."
She went on to say:
"He told me I would feel like a new person immediately after my surgery. I knew as soon as I woke up from the surgery that I was in trouble. I did not feel like a new person. My breathing felt a lot worse. I had a lot of complications only to find out he had implanted a device he had just invented and start implanting in patients one month before me.
I was never asked to sign an informed consent, nor was I advised that I was part of an experimental trial."
Ms. Vlahoulis said that by the time she had the device removed, the experimental ring had caused stenosis. She also needed her tricuspid valve repaired and now has a permanent pacemaker. She says she continues to have shortness of breath upon exertion as well as other heart issues. Her question remains unanswered:
"How can you place a non FDA device in a patient without their consent and knowledge? What century are we living in?"
Dr. Rajamannan Seeks Answers
Dr. Rajamannan informed Chief of Cardiology Dr. Robert Bonow, The Dean of Medical School Dean Jameson, the Institutional Review Board and the NMFF general counsel that there was a human clinical trial testing experimental devices without informed consent in July 2007.
Her report fell on deaf ears, as the University backed Dr. McCarthy and informed Dr. Rajamannan that she would no longer be seeing McCarthy's patients.
To make matters worse, Dr. Rajamannan discovered evidence that negative outcomes of the experimental trials were not reported in the process obtaining safety approval for Dr. McCarthy's inventions.
One patient, Ms. Maureen Obermeier, had a heart attack during surgery, and the event wasn't reported until five years later.
Dr. McCarthy had previously stated that no one had suffered a heart attack. Sadly, this isn't the only case of safety issues relating to the experimental devices.
Dr. Rajamannan states:
"I am trying to get the FDA and Congress to open a Congressional investigation to discuss the fact that the company and the surgeons did not provide the outcomes to the FDA until recently. The numbers were only a few hundred prior to the Fall of 2009, now the numbers are over 4,000 adverse events on the MAUDE database and the total number of deaths are 645. Patients are suffering from these human experiments and no one has stepped up to help these patients to date."
Money Above Human Life
Sadly, this isn't the only case of human experimentation by Dr. McCarthy.
According to Dr. Rajamannan, Dr. McCarthy has conducted at least four other human experiments, two at Northwestern and two at Cleveland Clinic.
In the case of one of these experiments, Atricure Inc. was ordered to pay $3.76 million in civil claims for its promotion of surgical ablation devices that were not FDA approved.
What would motivate doctors, who make the oath to do no harm, to play the part of a mad scientist and actually conduct secret experiments on human beings?
Simply stated, the motivator is money.
Doctors receive royalties for medical devices that are tested and approved. The added ego boost of being published in prestigious medical journals may make doctors forget that their first loyalty should be the well-being of their patients and not their bank accounts.
So while Dr. McCarthy continues to practice medicine on unsuspecting patients, apparently with an encouraging pat on the back from Northwestern, Dr. Nalini Rajamannan continues to fight for her patients and their right to know what was done to them.
When asked what she will do now that she has been terminated, Dr. Rajamannan responded:
"My hope is that Northwestern University Board of Trustees will review this situation and restore everything that was terminated for my career and provide a path for helping my patients who are suffering and restore the integrity of the University."
Top Secret Writers wish Dr. Rajamannan the best of luck.
(Note: Top Secret Writers contacted Dr. McCarthy for his side of the story. He declined to comment.)
- Atricure to Pay U.S. $3.76 Million to Resolve Medicare Fraud Allegations
- Maureen Obermeier vs. Northwestern Memorial Hospital - PDF Dr. McCarthy's Response
- Maureen Obermeier vs. Northwestern Memorial Hospital - PDF Northwestern Memorial's Response
- Northwestern U. Dismisses Medical Professor Who Questioned Cardiac-Surgery Chief's Safety Record
Permission to Reproduce from Kathleen Roberts, Top Secret Writers
http://www.topsecretwriters.com/2011/11/whistleblower-terminated-northwestern-human-experimentation/ 2011 Story from the Top Secret Writers- the posts on the ireport contain the chronology of the cover-up and the severe retaliation for the efforts to continue to protect the patients.
Kathleen Roberts is a freelance writer and editor with a special interest in health-related topics. Her main focus is uncovering ways to achieve health naturally while not becoming a lab rat for Big Pharma. Kathleen has 34 post(s) at Top Secret Writers
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