ABC's REBEL Parallels NorthwesternU's Heart Valve Clinical Trials

Katey Sagal portrays a patient advocate for patients who received heart valves which cause long term injuries for patients. The TV Drama parallels the real life story of the advocacy for patients who have not been informed of the testing of heart valves for 13 years and who have suffered serious injuries during the heart surgeries. Patient advocate Dr. Nalini Rajamannan has been interviewed by CBS in Rochester, MN, over the past year for her work to inform the patients, yet the Chicago hospital and the University Board has delayed treatments and full disclosure of what happened to the patients during experimental open heart surgery to repair their leaky heart valves.

NBC Interviews Dr. Rajamannan:

CBS Station KIMT Interviews Dr. Rajamannan in 2020:

TV DRAMA PARALLELS REAL LIFE DRAMA:

On April 8, 2021 the Series premiere of "Rebel" to air on the American Broadcasting Corporation, featuring Katey Sagal as Annie "Rebel" Bello. Katey Sagal has entertained audiences in a variety of dramatic and comedic roles throughout her notable career.

Inspired by the life of Erin Brockovich today, Annie "Rebel" Bello is a fearless legal advocate who fights for the underdog in society who does not have a voice.

The Series Premier is about the fight for 3,000 victims of a heart valve implant which causes "a life threatening autoimmune disease". The story parallels the true life battle fought by Dr. Nalini Rajamannan, A Mayo Clinic trained Cardiologist and Heart Valve Expert out of Most Sacred Heart of Jesus Cardiology and Valvular Institute, Sheboygan WI, Chicago IL, Rochester MN. Her fight to protect patients from untoward events dates back to 2007, when she first reported the experimental surgeries to her supervisors while working as an Associate Professor at the Prestigious Northwestern University Feinberg School of Medicine:

A story which began at the Cleveland Clinic dating back to 2005:

https://www.medscape.com/viewa...

"Wall Street Journal exposes lucrative ties linking Cleveland Clinic and top staff members to investigational device companies"- Shelley Wood

"Cleveland, OH - A page-one, 3500-word, investigative feature in the Wall Street Journal reveals a lucrative partnership between the Cleveland Clinic—and some prominent staff members—and companies manufacturing devices used in clinical trials there [1].
According to the report, by Journal reporter David Armstrong, more than 1200 patients since 2001 have undergone a radiofrequency ablation procedure at the Cleveland Clinic using an off-label device rejected three times by the FDA for cardiac use. The device is made by AtriCure, a company in which a venture-capital fund (Foundation Medical Partners [FMP]), created by the Cleveland Clinic to boost hospital coffers, owns approximately US $7 million in stock. FMP also invests in two other companies making products that are also in clinical trials at the Cleveland Clinic.
Ties between AtriCure and the Cleveland Clinic also involve prominent staff members, the Journal story notes. These include CEO Dr Toby Cosgrove, who, until March of this year, sat on AtriCure's board of directors, had invested in the fund personally, and was one of the general partners managing the company until he severed ties in October. According to the Journal, Cosgrove also worked with AtriCure on a medical device for which he will begin receiving royalties next year. As well, Dr Marc Gillinov, a surgeon at the clinic who has performed procedures using the AtriCure method, is a paid consultant to the company, as is Dr Patrick McCarthy, who has left the Cleveland Clinic for Northwestern Memorial Hospital in Chicago. McCarthy, says the Journal, performed the "AtriCure procedure" at the Cleveland Clinic and continues to use AtriCure devices at his current institution, receiving $2000 per month from AtriCure.
The AtriCure device is only FDA approved for the ablation and coagulation of soft tissue during surgery.

Cosgrove, who became CEO last year, stepped down from AtriCure's board of directors in March 2005 after a clinic conflicts-of-interest committee called for stricter guidelines governing clinic employee ties to industry and capped the amount staff could earn in consulting fees. The committee also requested changes to the consent form alerting atrial-fibrillation patients participating in clinical trials to the clinic's ties to AtriCure. Previously, none of the patients treated with AtriCure devices as part of research trials were told about the clinic's relationship to the company, Armstrong notes in his article. Yet so far, little has changed. "None of the patients undergoing the AtriCure surgery outside of clinical trials will see these disclosures," Armstrong writes. "So far, 1247 patients have had the AtriCure procedure at the clinic, including 16 who are enrolled in current clinical trials, and . . . clinic staff members have performed the procedure on 100 more patients in other hospitals. None of these patients saw the new consent form with added disclosure."
FMP has also invested $5 million in Immunicon Corp, a developer of cancer-screening products, and $3 million in CardioMems, which makes devices for endovascular repair of abdominal aortic aneurysms, Armstrong notes. The Cleveland Clinic also has a direct $2.75 million investment in Immunicon. Both Immunicon's and CardioMems's devices are in clinical trials at the Cleveland Clinic.
Armstrong quotes research ethicist, Dr Adil Shamoo (University of Maryland, College Park), saying: "The whole process of institutions having large-scale holdings in equities is corrupting the process. . . . It sends the wrong message and could lead to serious harm to human subjects because it clouds your judgment."
The startling details represent the second time this week the Cleveland Clinic has found itself the subject of negative press—uncommon for an institution frequently cited as the top hospital in the US. The clinic is also in the spotlight for its decision to strip renowned cardiologist Dr Eric Topol of his title as provost and chief academic officer, purportedly as a result of administrative restructuring, as reported today by heart wire. The changes to Topol's title and duties mean he is also off the conflict-of-interests committee and board of governors at the Cleveland Clinic.

Media reports have already raised the question of whether Topol's demotion is linked to his vocal condemnation of Merck's handling of Vioxx's Journal's revelations.
In an interview with the Journal, Cosgrove said that the AtriCure procedure is used because it is safe and effective, "not because of any financial considerations," Armstrong writes. According to the Journal, four patients have died during or following AtriCure procedures, but Cosgrove told Armstrong he was unaware of the deaths and believed off-label use of devices is "the nature of what we do and how we learn." He continued: "The important thing is the candor by which you discuss results and failures."
Some of that candor may occasionally have been lacking, Armstrong's story suggests. He points out that Cosgrove participated in a debate last year about whether atrial-fibrillation surgery should be done on patients having a heart-valve replacement. "[Cosgrove] mentioned only one company by name, AtriCure," Armstrong writes. "Not mentioned during the debate or in the disclosure section of the program guide was his seat on AtriCure's board or his investment ties to the company. A Clinic spokeswoman said his secretary mistakenly checked a box on a disclosure form indicating he had no conflict."
Elsewhere, Cosgrove and Gillinov coauthored a study on AtriCure surgery patients showing the procedure to be of benefit at six months. Although the journal disclosed Gillinov's role as a paid consultant, Cosgrove's was absent, something Cosgrove said it was "an oversight on my part," Armstrong writes.

The Journal article is not the first time Cleveland Clinic investments have fallen under scrutiny. A March 2005 article in the Cleveland Plain Dealer[2] also illuminated some of the ties between the clinic and device companies and quoted a clinic spokesperson as saying that since Cosgrove became CEO, he has been working "to identify, manage, and, if necessary, modify his relationships."

"Ties loosened after COI committee called for change Media attention, of the wrong ilk How we learn?"

Shelley Wood, Medscape, TheHeart.org

DOJ press release: https://www.justice.gov/opa/pr/atricure-pay-us-376-million-resolve-medicare-fraud-allegations

The Saga continued when the surgeon moved to Northwestern University in 2004....and here is the eye-witness account:

Dr. Rajamannan recently published story on the news site The Patch outlines her 13 years of seeking help for the patients, paralleling the story being told on the ABC Thursday in the Series Premier of "Rebel."

The Daily Northwestern published the update on the deaths, heart attacks and reoperations for the patients in May 2019:

In Focus: Years after surgery, new documents renew patients’ malpractice claims against Northwestern Memorial doctor

"Thirteen years ago, Northwestern Memorial Hospital’s renowned cardiac surgeon Patrick M. McCarthy began operating on his patients’ hearts using a new invention.

McCarthy designed the Myxo-ETlogix 5100 annuloplasty ring, devised to treat the most common form of heart disease, called “myxomatous mitral valve disease.”"...

"McCarthy’s annuloplasty ring was designed to improve his patients’ health, but just years later, his invention was in deep water — it had faced a U.S. Food and Drug Administration rebuke and several lawsuits from patients alleging the surgeon performed human trials for the ring without their consent. It has also been subject to investigations by the FDA and U.S. Senate, both of which ultimately fizzled out."...

"In February, Obermeier filed a petition to overturn the dismissal of her 2008 lawsuit, which alleged poor medical treatment by McCarthy. The petition is based on new information revealed through a Freedom of Information Act request showing that, at the time of her 2006 surgery, McCarthy’s annuloplasty ring was not FDA-approved and the surgeon was not given permission from Northwestern’s Institutional Review Board to operate with it.'

"After reviewing her hospitalization charts from 2006, the cardiologist found elevated troponin values and concluded she suffered a heart attack during her surgery and multiple episodes of cardiac arrest within 24 hours of the operation, Obermeier said.

Obermeier said McCarthy assured her that her surgery went smoothly, she received no medical follow-up and was administered no treatment for her heart attack.

“He had nothing to say about what happened during the surgery,” Obermeier said of McCarthy. “So it was like I got lied to.”'

"McCarthy later confirmed the heart attack in a 2011 court hearing and 2012 legal deposition...."

"According to documents from her FOIA, the Northwestern Institutional Review Board — a group responsible for protecting the rights and welfare of human subjects involved in research at Northwestern — authorized McCarthy’s research on the ring in 2006. Its understanding, documents show, was that his studies would be retrospective."

"That meant McCarthy was only authorized to review past medical records of patients who had undergone mitral valve repair between April 2004 and June 2006. He was not granted permission to operate with the Myxo ring. However, The Daily obtained a 2005 Edwards Lifesciences document from Rajamannan that recorded McCarthy’s input on the design of the ring at the initial stages of the device’s development. The document said McCarthy intended to operate on at least 10 patients with the prototype."

"“Dr. McCarthy indicated that if the first 10 implants went well, he would feel comfortable expanding the use of the device to other surgeons,” the document stated...""

"These operations were carried out without IRB approval and took place before McCarthy’s IRB request to review past patient records. When McCarthy filed a new request to expand his review into 2007 records, the board determined his research was no longer retrospective and requested for additional information. Instead of submitting details about his research to the IRB, he decided to terminate it altogether."

"In 2007 emails obtained by The Daily, a representative from McCarthy’s team confirmed to the IRB that the research project would be closed. After further consideration, we have decided to terminate this project,” the email said. The email also confirms that no research has been done since McCarthy’s approval for retrospective reviews expired on June 27, 2007.

These operations were carried out without IRB approval and took place before McCarthy’s IRB request to review past patient records. When McCarthy filed a new request to expand his review into 2007 records, the board determined his research was no longer retrospective and requested for additional information. Instead of submitting details about his research to the IRB, he decided to terminate it altogether. In 2007 emails obtained by The Daily, a representative from McCarthy’s team confirmed to the IRB that the research project would be closed."

“After further consideration, we have decided to terminate this project,” the email said. The email also confirms that no research has been done since McCarthy’s approval for retrospective reviews expired on June 27, 2007. However, his 2008 publication in The Journal of Thoracic and Cardiovascular Surgery — titled “Initial clinical experience with Myxo-ETlogix mitral valve repair ring” — stated that “100 patients received the Myxo ring, which is a Food and Drug Administration-approved ring.”"

Amy Li, Web Editor The Daily Northwestern
May 23, 2019

https://dailynorthwestern.com/...

Patients need to be told.....FDA, Northwestern University and Edwards Lifesciences needs to inform the patients.