Who am I? I have written on the Dr Timothy Kuklo, Washington University in St Louis School of Medicine case extensively which dealt with the Medtronic disgrace with falsified research, misleading data, fake co-authorships and the like. I wrote more on this case than any other online source and have gotten 10,000s of hits. But, who am I? I am a patient at Northwestern Bluhm Cardiovascular Institute and I have noticed that patients’ views are considered inconsequential by both the press and Northwestern unless they are litigants. Interesting if not elitist. Well I have strong views on this scandal and a stake in its outcome.

Dr Rajamannan: Heroic Northwestern cardiologist who protects and advocates for her patients.
I have been a patient at Northwestern for ten years and have been treated by Dr David McPherson, who is now at the University of Texas Medical School in Houston, and Dr Jyothy Puthumana. They are cardiologists and are exceptional, attentive, creative and deservedly of high reputation and achievement. I have never met Dr Patrick McCarthy nor Dr Nalini M. Rajamannan but I know full well the issues of using for clinical trials, unsuspecting patients needing heart-valve replacements or in this case mitral-valve repair. I should add I was diagnosed also with mitral-valve prolapse but Northwestern has removed me from this diagnosis due to new diagnostic guidelines and frankly the creative wonders of their cardiology department. Of course heart surgeons are NOT cardiologists and at the Galter Pavilion in downtown Chicago, they share the same 19th floor but a different pavilion.
Who am I? Well, I have a heart murmur, aortic regurgitation, aortic insufficiency which means my bicuspid valve forget its third leaflet probably while in gestation. I also have an aortic aneurism but with less than one percent chance of dissection. Yeah, I do resistance training and run 3.9 miles or so six days a week and I am asymptomatic. Basically, I was born most likely with a heart valve that does not close properly and, hence, when it pushes blood through the body, some of it falls back into the left ventricle. At some point, I will need aortic-valve replacement in which my aortic valve is removed and replaced with a pig or cow valve which lasts for decades and does not need daily warfarin management (blood thinners which are a real bummer). The surgery is very safe with a morbidity rate of between 1-2%. One of the reasons it is safe is that the Food and Drug Administration (F.D.A.) approves every device that is implanted and the surgeons for the most part are dedicated to saving their patients from progressive cardiovascular and/or valvular disease and restoring them to health and fitness.

Myxo ETlogix annuloplasty ring 5100 (Source: Edwards Lifesciences)
http://www.theheart.org/article/909595.do
Dr McCarthy tweaked this into a triangle-shaped device without F.D.A. approval prior to implantation in 150 patients. It looks mechanical to me and I wonder if patients have to be on anticoagulant blood thinners every day for life? Those are not a walk in the park but to a hospital clinic every week or so to test the blood-thinners. Ok, I am just a Ph.D. in history but patients are not stupid and in gaping, awe of their physicians regardless of conduct.
Who am I to comment on the McCarthy v. Rajamannan dispute? Well I would not want a device such as the Myxo ETlogix annuloplasty ring 5100 implanted in my heart, even for mitral regurgitation repair and not replacement, that was not F.D.A. approved. Duh! I don’t need to be treated as a guinea pig by a for-profit surgeon with an eponymous device that was modified and not PREVIOUSLY peer reviewed in the literature and not subject to clinical trials under F.D.A. approval. Dr McCarthy implanted in about 150 patients an experimental device used for mitral valve regurgitation: the heart has four valves and McCarthy is an inventor of valves for the mitral valve. Some of his patients required explantation or removal of the mitral valve device that was altered by Dr McCarthy without receiving F.D.A. approval: namely clinical trials must precede patient experimentation. I do not know if the modified device was the cause of illness in some of his patients but there are lawsuits galore against McCarthy and Northwestern. Hardly surprising if not salubrious hopefully to deter such medical “wild-west” shows.

I concede there are grey areas in which F.D.A. approval is not always clearly mandated. Yet a physician, even a “star” grabbed from the Cleveland Clinic, by image conscious Northwestern Memorial Hospital, should exercise logical, rational restraint. Don’t implant without testing. Don’t skirt the edges of F.D.A. mandates since the prize, the purpose is wellness and patient care. Maybe Dr McCarthy should spend a year on “paid leave” in community clinics, or inner-city hospitals and get a taste of the real world outside Streeterville–a posh area on the Gold Coast astride the Magnificent Mile of Michigan Avenue.
Dr McCarthy claims that he merely “tweaked” the F.D.A. version and, hence, made minimal alterations not requiring further “expensive, time consuming” clinical trials. I think this is very poor judgment and a challenge to the system in place that monitors surgical practices at Northwestern and the Bluhm Cardiovascular Institute. I have had a consult with Dr Chris Malaisrie, who is at Bluhm at Northwestern and an impressively credentialed cardiothoracic surgeon and he struck me as thorough, honest and empathic. {I did see Dr McCarthy in the hall when I was with Dr Malaisrie but have not met or spoken to him as noted earlier.} Yet I am hesitant, very hesitant to have device(s) implanted in my heart that have not been previously subjected to rigorous testing.
Northwestern is backing its “man” and declared he merely performed “minor modifications” on the mitral ring and has decided not to buy him out or fire him. It could at least order emphatically that full disclosure of his financial stake in cardiovascular devices be clearly and unambiguously communicated to patients prior to consent! I wonder if Dr McCarthy’s actions have been investigated by a neutral, non-Northwestern medical-ethics review board? Have patient-activist advocates been consulted? Northwestern should back Nalini, who is basically a whistleblower, who has the courage and a commitment to her taking the Hippocratic Oath: “Do no harm” to challenge the “star” and “bread winner” for Northwestern’s cardiovascular department. She has been a voice of dissent, a voice of courage, a voice of conscience and demurral against deploying unsuspecting, very sick patients as possible experimental subjects for one’s financial and professional ambitions.
That is wrong, unethical and possibly very damaging to patients! This is about decency. This is about honour although I do not know Dr McCarthy personally. This is about patient safety. Not without supervision “tweak,” alter, modify, HEART VALVE DEVICES, without full disclosure to patients.
I ask this of Dr McCarthy. If you were merely making modest modifications with the Edwards’ Myxo device and weren’t altering its functionality or efficacy, then why reshape it? What was your reasoning in changing the shape of the device? Yes the shape that sounds like more than a mere pinch or two but a major modification. Why modify in the first place if it were so inconsequential that you did not seek governmental, or peer-professional approval that the device could pass clinical trials? You can’t have it both ways especially when the lives of your patients are at issue.
When I was in Dr Malaisrie’s office, I was handed a sheaf of documents, without oral instruction, by a nurse practitioner. One of them was to give consent on being part of a test-cohort following surgery. I thought this was odd if not premature since I had not even been examined yet much less recommended for open-heart surgery. No one attempted to explain it to me. No one went over the parameters of these written consent forms. I refused to sign it in part because of my fear I might be used inappropriately as a test-subject for investigational devices and wondered what were the benefits in signing: other thanmaybe advancing generally the progress of medicine. Dr McCarthy’s name was on the document and while presumably a form used in many clinical settings, I thought it was too presumptuous, rather hasty and in part intimidating. To patients: don’t sign anything until you have read it, and understand it. Just don’t sign until you know YOUR rights and YOUR health are not being compromised.
Who am I? A patient at Northwestern who will remain there as a cardiology pateint but will not, when the day comes, place myself in the cardiovascular or cardiothoracic department with this cloud, this ethical wrong, hanging over its reputation. I am incensed that any physician would engage in this type of ad lib, monkeying around with valvular devices without any sense of humility or restraint. I am elated that a phyisican, Dr Rajamannan, without the clout or the money-making heft has the fortitude and the professional ethical brilliance to fight, resist, and challenge the all powerful Dr McCarthy and his insouciance toward patient care. Yes I know he has his side of the argument but I have mine and the right and the willingness to speak out for those of us who have or will with certainty face the day of open-heart surgery. Our time has come to insist the profession of medicine reward only those surgeons and physicians who construe it a privilege to care for and heal patients.
The author is the son of Melvin B. Kirstein, M.D. an internist who taught at the Washington University in St Louis School of Medicine and co-authored with Michael Somogyi the pathbreaking article on diabetes and the “Somogyi Effect.”
comments are welcome to kirstein@sxu.edu
Other Kirstein posts:
January 1, 2010 Did the McCarthy Myxo Ring Require F.D.A. Approval? Dr McCarthy’s Article Described it as “Initial” and “New.” http://english.sxu.edu/sites/kirstein/archives/4151
December 29, 2009 Dr Nalini Rajamannan: Curious “Reassignment to Other Duties” and Additional Academic Freedom Concerns
http://english.sxu.edu/sites/kirstein/archives/4061
December 28, 2009 Did Northwestern Retaliate Against Dr Rajamannan? Was her Academic Freedom Violated?
http://english.sxu.edu/sites/kirstein/archives/4002
December 26, 2009 Part II: Mitral Valve Ring War Between Dr McCarthy and Dr Rajamannan: Race, Class, Gender and Patient Rights. http://english.sxu.edu/sites/kirstein/archives/3964
Other articles on this dispute are:
Chicago Tribune 12.24.09
Wall Street Journal 12.23.09 Since it is online subscription, I was able to get full text through Google that Rupert Murdoch, owner of the WSJ, wishes to bypass! Good luck Mr Conservative who employs FOX news hosts who call the president of the United States: racist!!
BY ALICIA MUNDY AND JARED A. FAVOLE
At Northwestern University’s prestigious research hospital, one heart doctor is making a serious accusation against another. Nalini Rajamannan alleges that Patrick McCarthy, her former professional idol, engaged in “human experimentation” on patients’ hearts without their approval.
Dr. McCarthy, a noted surgeon, categorically denies it. “Does that sound plausible?” he says. As part of the brawl, Dr. Rajamannan sought a financial agreement with Northwestern that included a $2 million endowed research chair.
The dispute centers on a silver-dollar-sized piece of silicone and metal known as a Myxo ring, used to pinch together leaky heart valves. Dr. McCarthy invented it. And he implanted it in more than 150 patients before the device received approval from the Food and Drug Administration.
Because of the controversy, the FDA retroactively examined and approved the Myxo ring and said it is “safe” as used.
Yet the clash between the two doctors — once close collaborators, now bitter foes — is causing the FDA to re-examine a little-known but critical part of its approval guidelines, which it says are ambiguous. Currently, this section lets device makers decide on their own, without FDA input, whether or not some new devices require regulatory approval.
William Maisel, director of the Medical Device Safety Institute at Harvard Medical School, said the current FDA procedures represent a “giant loophole” that medical-device makers can use to sidestep scrutiny. He called the Myxo case a “poster child” for the issue.
The Myxo ring’s manufacturer, Edwards Lifesciences Corp., says it believed the Myxo ring didn’t need to be submitted to regulators because it was similar to previously approved heart-valve rings it makes.
Northwestern University and Dr. McCarthy say they relied on the manufacturer to get FDA approval. The matter has spawned two lawsuits, a Senate investigation and worries in the medical-devices industry about the potential effect on the bottom line of manufacturers.
There is no way to know how many medical devices may have followed a similar path to use in patients since 1997, when a guidance document allowing this flexibility was introduced. But both industry and regulators say this guidance may have saved the industry hundreds of millions of dollars during that time.
Jeffrey Gibbs of Washington law firm Hyman, Phelps & McNamara, which represents device makers, defended the current rules, saying the industry needs the “gray zone” to avoid redundant new-device applications. “It would be a nightmare for the FDA, and companies, if they had to apply for each tweak” to an already-approved device, he said.
The rules permit the sale of certain new devices without the need for regulators’ approval if the device is a version of an FDA-approved product from that same company.
A change in FDA procedures could require expensive clinical trials, Mr. Gibbs said, and in some cases retroactive re-examinations of devices now in use that weren’t previously submitted for approval.
For hospitals, heart surgery is a powerful revenue engine, and surgeons who make the “best doctor” lists are the high-priced stars who drive it. One mark of distinction they covet is a device named after themselves.
When Dr. McCarthy moved to Northwestern from the Cleveland Clinic in 2004 as co-director of a newly created heart institute, he was developing the McCarthy Myxo heart valve ring. That year, he filed a patent application for the Myxo, which he created by bending an FDA-approved oval ring into a triangular form.
The arrival of Dr. McCarthy was a big deal at Northwestern, says Dr. Rajamannan. “He’s one of the top surgeons in the country and has amazing technique, and our daily volume [of surgeries] jumped,” she says. “We all were dying to work with him.”
The daughter of Sri Lankan immigrants who came to Minnesota, Dr. Rajamannan, 46, says she wanted to be a doctor since she was three.
Dr. McCarthy, 54, son of a surgeon, chose that path later — in second grade, he has said. Both went to Notre Dame and later worked at the Mayo Clinic in Minnesota.
Dr. Rajamannan’s innovative research at Mayo and Northwestern on heart-valve problems earned an invitation from Dr. McCarthy in 2006 to be part of a paper he was going to publish on his Myxo invention. “I was very excited,” she says.
That year, both heart specialists shared a page in Chicago Magazine’s “Top Doctors” issue.
One of Dr. McCarthy’s early implant patients was Antonitsa “Toni” Vlahoulis, then a 38-year-old X-ray technician and a mother of two, who suffered from a life-threatening mitral-valve disorder. The heart has four valves that keep blood flowing in the right direction. Dr. McCarthy’s ring is designed to keep the mitral valve closing and opening correctly so blood doesn’t back up into the lungs.
Dr. McCarthy’s valve repair at first appeared to clear Ms. Vlahoulis’ shortness of breath. But then her breathing worsened, she says, sending her frequently back to her cardiologist.
Ms. Vlahoulis says she was surprised when she received a “warranty card” in the mail — the kind of postcard that appliance makers send after a purchase. It was for her new implant: the McCarthy Annuloplasty Ring Model 5100.
She realized the product wasn’t listed in the catalog of heart rings she says Dr. McCarthy had given her before surgery. She says Dr. McCarthy had told her she would receive one of the rings in the catalog.
Dr. McCarthy said he told her she would receive an implant of this type.
She was readmitted to the Northwestern hospital in 2007. That spring she told Dr. Rajamannan, who was following her case, that she hadn’t signed a consent form specifically for Dr. McCarthy’s device.
Ms. Vlahoulis did sign two forms approving the surgery in general and allowing the results to be used for research. Northwestern has said those forms amount to informed consent for use of the device.
Dr. Rajamannan learned that Northwestern hadn’t convened an institutional review board, an oversight panel required whenever patients are being given experimental medicines or devices. She says she asked Dr. McCarthy why he was conducting a clinical trial without patient consent. The collaboration between Drs. McCarthy and Rajamannan fell apart.
Dr. McCarthy says it is common for surgeons to try out tweaks to devices without going through the whole clinical-trial process. Asked whether he thought he should have asked for a review board, he said: “Not even remotely.”
The university says it didn’t convene a review board or ask for special patient consent because there was no clinical trial.
Dr. Rajamannan says she believes the use of the ring did represent a clinical trial. She says Dr. McCarthy should have told patients that he was implanting an unproven device on which he was making money.
Dr. McCarthy says he consults for Edwards but royalties from the Myxo ring go to a Chicago food bank.
Dr. Rajamannan’s accusations put the university administration on the spot. The chairman of the cardiology division separated Dr. Rajamannan from duties involving Dr. McCarthy’s surgery patients, she says.
The university legal office and Dr. McCarthy scrambled to get reassurance from Edwards Lifesciences that the FDA had authorized use of the Myxo ring. In September 2007, Edwards responded that the ring had been “marketed in the U.S. since March 2006″ pursuant to the FDA’s 1997 guidelines. The company also stated it wasn’t an experimental device.
Toni Vlahoulis claims a medical device, the Myxo heart-valve ring, damaged her heart. Ms. Vlahoulis had to have her Myxo ring “explanted” — taken out — at the Cleveland Clinic. In spring 2008, she sued Dr. McCarthy, Edwards and the university in Cook County Circuit Court, claiming the ring worsened her heart-valve problem.
Dr. McCarthy, Edwards Lifesciences and lawyers for the hospital maintain that the ring is safe. Dr. McCarthy says he sympathizes with Ms. Vlahoulis but adds, “I can’t wait to get to court” to explain his decisions.
Ms. Vlahoulis and Dr. Rajamannan are both represented by the same lawyer, a friend of Dr. Rajamannan’s who attended Notre Dame with her more than 20 years ago.
Of the more than 150 implants of the Myxo ring so far, Ms. Vlahoulis is one of only two patients known to have sued. A separate lawsuit filed by another patient in the same court alleges that the ring damaged a coronary artery and caused a heart attack during surgery. Edwards, the hospital and Dr. McCarthy declined to comment on the litigation.
In the summer of 2008, the medical-journal article Dr. McCarthy had been working on for two years was published in the Journal of Thoracic and Cardiovascular Surgery. Dr. Rajamannan’s name had been on an earlier version, but she pulled it from the final article, saying she didn’t want to be associated with his research.
In the article, Dr. McCarthy and collaborators wrote that they were describing their “initial experience with a new ring” — language cited by Dr. Rajamannan to suggest that Dr. McCarthy should have sought clinical-trial approval.
He says that wasn’t necessary. It’s “not a new shape,” he said in an interview. “We’ve been taking pre-existing [rings] and bending them for quite a while.” The Myxo ring doesn’t use new materials, and it doesn’t carry a risk of allergic reaction, Dr. McCarthy added.
Ms. Vlahoulis, the X-ray technician, saw the journal article. It said the Myxo ring worked in most cases, but mentioned one patient who required full replacement 13 months after surgery. Ms. Vlahoulis recognized herself.
The publication of such an article suggested that she had been part of a de facto research trial, says Ms. Vlahoulis. But “I never was asked,” she says. “I didn’t want to be a guinea pig.”
In an interview, Dr. McCarthy said the article wasn’t a clinical study but part of a database on heart-surgery results, and that patients gave consent to be in the database.
Ms. Vlahoulis emailed the FDA for information on the Myxo ring, which she couldn’t find on the agency’s Web site.
There was a reason for that. “We have not approved the McCarthy Myxoetlogix Annuloplasty Ring 5100 model,” an FDA official wrote back to Ms. Vlahoulis on July 30, 2008.
Ms. Vlahoulis contacted Dr. Rajamannan, who says she had assumed the device was FDA-approved. Dr. Rajamannan contacted the FDA, and says she also confronted Northwestern officials, whom she accused of failing to follow through on her allegations of a year earlier.
Another of Dr. Rajamannan’s lawyers sent Northwestern requests on the doctor’s behalf. They included the $2 million endowed chair for heart-valve research, apologies from Northwestern officials, the dismissal of some employees, staffing help for her laboratory’s mouse room, and $1 million to Dr. Rajamannan’s retirement account, according to letters reviewed by The Wall Street Journal.
Dr. Rajamannan confirms some details of her requests, but says she never asked for money “to shut me up.” At the time, Dr. Rajamannan says, she was fearful for her career because she was challenging one of Northwestern’s most important doctors, and because the university refused to meet with her on her allegations.
The university says it responded to Dr. Rajamannan and that it hasn’t agreed to her requests.
In mid-August 2008, the FDA contacted Edwards Lifesciences about the situation. In ensuing conferences, the FDA told Edwards that the company’s interpretation of the 1997 guidance document was “incorrect.” The alteration to the ring should have been flagged to the agency, FDA officials said.
The agency acknowledges that its guidance document is “not entirely clear.”
In October 2008, Edwards pulled the Myxo ring from the market and submitted an application to the agency for it under a new name. The company also filed an application for another valve ring Dr. McCarthy had invented, which had been available since 2003.
The agency retroactively approved both devices in April of this year under its 510(k) process, an abbreviated review for devices that are judged similar to existing products. Edwards says it returned the ring to the market. It costs between $2,500 and $4,000.
The compliance director of the FDA’s device division says Edwards acted in good faith and the agency “had no evidence of intent to mislead or deceive.” However, he said, “The next event could result in penalty.”
Bram Zuckerman, director of the FDA’s Division of Cardiovascular Devices, says the FDA is considering asking companies to contact the agency upfront if they plan to change devices. The review is part of a larger upheaval at the FDA under Commissioner Margaret Hamburg and her chief deputy, Joshua Sharfstein.
The head of the agency’s device division resigned in August and the next month the FDA released a scathing report about his actions in approving a knee device last December, citing a Wall Street Journal investigation of that issue.
The Senate has been investigating the Myxo ring since late last year, with Dr. Rajamannan’s assistance.
Dr. McCarthy, recently named director of Northwestern’s Bluhm Cardiovascular Institute, notes that he was vindicated in an investigation by Northwestern’s ethics office. Dr. Rajamannan says she would like her complaints vindicated as well, but is “very happy” continuing her research at Northwestern. She and Dr. McCarthy work in different buildings, and she says they don’t bump into each other.