” …Five Stars! This book is an on-target indictment of dangerous, unethical, and money-driven factions within our health care industry. Many ill patients receive quality care in America, but far too many are also victims of the dark heart that poisons American healthcare. Read it. It could save your life.”
– John T. James, PhD, Patient Safety America
“You need to read this book… Excellent writing. It reads like a crime novel, but the story is true.”
“Must read for everyone prior to surgery – patients AND doctors. Concise, well researched – you will learn the questions you should ask prior to scheduling any procedure. A frightening summation of a family’s tragedy when treatment and ‘care’ are not the priority.”
“A searing, poignant and cautionary tale. This book has really shaken me. I urge everyone to read it….”
“I am on my second reading of this book. And I will probably have to read it several times to have its sheer magnitude sink in. It is truly astonishing.”
“It is a book about big business, the drug and medical products business, teaching hospitals, and much, much, more…”
∞
Preview CHAPTER ONE:
“A Mitral Valve, Flapping in the Breeze, Prolapsed into the Atrium …”
JOHNS HOPKINS MEDICINE has a long tradition of prioritizing patients, and striving for the bottom rung are the anonymous poor. If, for example, you catch a bullet on a Baltimore street corner, or your mother presents you at the ER as a feverish welfare child, then it’s open season for the med students, well meaning as they may be. They can practice on you because if their actions result in an adverse outcome—which is to say that if you are mangled or killed—nobody will question said outcome, precisely because… you are a nobody.
At the other end of the spectrum are wealthy and prominent patients, who get treated by doctors who have already learned what not to do from the mistakes inflicted upon the lower classes.
My wife landed somewhere in the middle. We got snookered by all the hype from US News into thinking that she was going to be treated by the best doctor at “The Best Hospital in America.”
Hugh Calkins, MD was to maneuver tiny wires around in my wife’s heart and burn scar tissue in the wall of the atrium to stop atrial fibrillation.
The job required someone with a cool head and a keen eye, and Hugh Grosvenor Calkins, MD, FACC, FAHA, FHRS, Professor of Medicine, Director of the Electrophysiology Lab at Johns Hopkins University School of Medicine—and graduate of Harvard Medical School—assured us that he had done plenty of these procedures, and, he said, “experience counts.” So we knew we were in the best of hands. What we didn’t know is that Professor Calkins—according to what he later told colleagues—follows the practice at most teaching hospitals wherein “the attending shows up to be there during the burn.”
What he meant by that was this:
The patient is etherised upon a table and wheeled into the lab. A student of the treatment performs routine aspects of the procedure. According to the rules, all this is to be done under close supervision. Under bright white light, the rookie’s blue latex fingertips feel their way up the smooth soft skin of the exposed groin, goose bumps because it’s cold in the room, pressing and probing and picking a spot, the point of a large bore needle pressing into the skin until it punctures and there is blood.
The trainee then inserts the sheath for the catheter into the vein and snakes it up into the pumping heart. The catheter wire is then fed into the sheath. This is the point at which you would expect the experienced attending physician to step in because it is a very tricky business to navigate a thin wire around in a beating heart guided by cloudy X-Ray imagery, even if you know what you’re doing.
But since he only “shows up to be there during the burn,” Hugh Calkins was presumably relaxing with colleagues down in the doctor’s lounge or out selling TASER guns while a young cardiology trainee by the name of Richard Wu—whom we’d never
met—was sweating out a decision in the lab. He had a stranger laid out before him and a new type of catheter in his hand.
It appears that young Wu wasn’t sure about which chamber of Pam’s heart to insert the catheter. He went for the left ventricle (it says right on the box to not do that). The catheter tip got tangled in the web of muscles that operate the heart’s mitral valve. Her chart read: “only the first 50% of the circular portion of the catheter tip could be withdrawn into the sheath and pulsatile motion could be appreciated.”
Pulsatile motion.
They were pulling on the catheter, trying to cajole it off the snag, but it was tugging right back, like they’d hooked a five pound bass. A nurse noted here that the “patient is waking and moving around, with chest pain @ 7/10.”
***
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i am very surpised at all the negative comments related to JH as this side of town they are woshipped …….Sad state of affairs as patients receive the worst end of it.
New heart rhythm fix sometimes short-lived
NEW YORK | Fri Jan 6, 2012 5:16pm EST
(Reuters Health) – A new procedure to treat the common heart rhythm problem atrial fibrillation may offer only short-lived relief for a significant portion of patients, according to California researchers.
http://www.reuters.com/article/2012/01/06/us-heart-rhythm-idUSTRE80520O20120106
Dan,
What was the result of your appeal of the court decision in which you sued Calkins and Hopkins?
Did your appeal succeed?
I cannot believe that the judge in your case refused to allow the jury to hear the case.
Did Hopkins bribe the judge?
Henry Alken
Hello Henry! Thanks for the note.
We won our first appeal on the grounds that we do not need an expert witness to bring an informed consent case. The case was thrown out again, the judge ruled, because we did not have an expert witness.
The case is currently back before the Court of Appeals, which is in Annapolis — not six blocks from Johns Hopkins Inc., where the circuit court operates.
I am very grateful for these posts. As a former R.N., who has experienced atrial fib and had invasive tests, I am grateful to be more informed about other’s experiences with the ablation procedure. I may need one someday. Personally, I was shocked by the inaccurate info that resulted from a variety of high-tech, including radio-active assessments that led to my angio-gram that was normal. Here in B.C., my ordeal involved attending 3 different hospitals. The angiogram was done at St.Paul’s, a teaching hospital in Vancouver. I made sure that the specialist was doing the procedure himself. After reading the posts here, I’m so glad that I did. I was awake for the insertion of the catheter and the ‘photography’. I could feel the ‘camera’ as it entered my heart. It was an interesting experience that went well.
I recently was a patient of Dr.Blaney (Vancouver, B.C.) who along with Trevor Marshall (California based) ‘administer’ The Marshall Protocol. It involves a drug called Olmesartan in Canada, Benicar in the U.S. People challenged with chronic illness, in particular Lyme, CFS, fibromyalgia are the vulnerable population. Many of the ‘patients’ experience arrythmia’s before starting the protocol. I write this post to make the statement that I believe that the MP is dangerous. After frightening adverse effects to the drug, on my heart, I have done further research and found that the studies quoted to back the safety of the MP are mostly on rats or ex-vivo and in the human trials only at a doseage of 20-40 mg per day. Although deemed safe by the FDA at 40 mgm per day, The M.P. involves 40 mgm every 4 hours. It has been my experience that this doseage likely leads to toxicity which causes cardiac pathology. It has come to my attention that folks on The M.P. are attending the E.R. with very low blood pressure and arrythmia’s. I would greatly appreciate resources/direction as to what I should do next. My concern is for sick people who may get a whole lot sicker on this ‘protocol’ that is highly questionable. I have informed Dr.Blaney and the leader of the Lower Mainland Lyme Support Group.
Interesting perspective! And we, the patients, should be involved and take responsibility in our lifestyle choices and health care.
http://www.themitralvalve.org
So, did she live? Or is this really a teaser because someone whants to sell a book?
Blog post concerning FDA’s 510(k) process:
Dangerous Medical Devices: A Personal Story
A real eye-opener. My experience mirrors some of Mr. Walters’ except I started asking questions about Tikosyn, Niaspan, and catheter ablation, which was strongly recommended for me, even though I have no symptoms. I got curt two-word answers and a clear expression of annoyance from my EP. That was in February. Now it’s August and he has cancelled my last 7 appointments. Is he trying to tell me something or am I over-reacting?
On a different subject, has anyone read Dr. Calkins’ ebook: “Atrial Fibrillation: The Latest Management Strategies?” Is it trustworthy and accurate?
call Dr. Larry Chinitz,Director of the Arythmia CEnter at New York University. I had a catheter ablation and am doing great! he is wonderful, the only bad thing is he always runs late on his office visits. Howevr, he is in the OR the entire time doing your ablation and is there at 11 or 12 midnight sitting by your bedside.
Silent-embolization concerns mount for RF ablation catheter
AUGUST 3, 2011 | Michael O’Riordan
Heartwire
Bad Krozingen, Germany – Two recently published studies are raising concerns within the electrophysiology community about the risks of silent cerebral thromboembolic events in patients undergoing radiofrequency (RF) catheter ablation for the treatment of atrial fibrillation. Specifically, the two studies suggested that pulmonary vein isolation using a multielectrode phased-RF ablation catheter (Medtronic Ablation Frontiers) for the treatment of atrial fibrillation is associated with a significantly higher rate of asymptomatic intracranial embolic events compared with externally irrigated and cryoballoon ablation catheters.
In the first study [1], now published in the August 9, 2011 issue of the Journal of the American College of Cardiology and reported earlier by heartwire when it was available online, Drs Claudia Herrera Siklódy (Herz-Zentrum, Bad Krozingen, Germany) and colleagues report that postprocedure MRI revealed a new embolic lesion in 37.5% of patients treated with the multielectrode RF ablation catheter, compared with 7.4% of patients treated with a conventional irrigated catheter and 4.3% of patients treated with the cryoballoon ablation catheter (Arctic Front, Medtronic).
………………………………………………
I just had an ablation and I’m experiencing more abnormal heart rythms now than before I had the procedure! Needless-to-say, I am very disappointed. Now I have to double the medication that I thought I’d be going off of. BIG disappointment!
WAKE UP EVERYONE ! What did you think a “teaching hospital” was…didn’t you do some general reading, let alone some solid research. Now to tag Hopkins as racist experimental hot bed for the poor, the rich, and the stupid middle income folk, is beyond any objective and wise insight a person could have.
You’re right. I had foolishly assumed that a teaching hospital was a place where excellence in care and compassion was taught. Had I done some solid research, as you suggested, I would have learned that teaching hospitals are very dangerous places where corporate profits trump patient safety and doctors lie to protect their standing.
I have woken up, and will never repeat the mistake of trusting doctors at Johns Hopkins.
I have read and re-read the passages relating to your comments above. I would now ask you to do the same. I am unable to locate any discussion about race unless you are equating the lower class with a particular race. I do not see where Mr. Walter called the middle class stupid, and I certainly don’t see where Mr. Walter claims the rich are being used as experimental patients at Hopkins. In fact, I think Mr. Walter firmly believes unless you are rich and/or powerful in some way, you have very little value at Hopkins as a human being regardless of your race.
Finally, and most importantly, over the past 10 years of dealing with my mother’s illness, I have done more than my share of general reading and as much solid research as my intellectual ability allows (and I did graduate from an Ivy League college with honors). I have been AWAKE countless hours reading and researching and based on the information I gathered, I made a conscious decision that a “teaching” hospital would be the best place for any patient. My decision was further confirmed, as I assume Mr. Walter’s decision was as well, by the huge reproductions of US News and World Report claiming Hopkins the best in the country nearly every year over the past 20+/- years. These magazines covers were a comfort to me as my mother lay upstairs on death’s door. Hopkins went behind my back and did things I told them not to do. Hopkins held information from me on her condition. Hopkins tried to kick my mother out of the hospital while she was still gravely ill. Hopkins lied on their documentation making it impossible for me to get her into a rehab facility and nearly cause Medicare to stop paying her bills. Hopkins did many, many more dirty deeds while she was there. Yet still, after all of this, I still believed in the value of a teaching hospital.
I bought Mr. Walter’s book… It confirmed many, if not all, of my undisclosed thoughts, concerns and fears about the “teaching” hospital. If only I had found Mr. Walter’s book two months ago…..I would never have allowed my mother to enter another “teaching” hospital. My mother died last month in a “teaching” hospital in Washington, DC, because they performed a procedure on her she neither wanted nor needed, because they got her to sign a consent form when we were not around to tell her we had concerns, because they withheld information from our family that would have allowed us to make a better informed decision, because they came to me over the phone to consent to a procedure she supposedly needed yet she was awake and alert and could have consented herself, because they refused to sit down with my brother and me and talk about risks and benefits, because they performed other procedures without consent and claimed a previous consent could be used as a blanket consent, because they had interns communicate with me who had NO IDEA WHAT THEY WERE TALKING ABOUT. If only I had read this book two months ago, I wouldn’t have questioned myself as the doctors intimidated me with their belittling comments and assaults on my intelligence and my mother would likely be alive today.
NOTE TO MR. WALTER: It was not “foolish” of you “that a teaching hospital was a place where excellence in care and compassion was taught.” I did the research, I asked other doctors, I scoured the internet and never once was I steered away from the “teaching” hospital. I did not ask the right questions…..I didn’t read between the lines…..I didn’t google malpractice. I was “foolish” enough to believe in US News and World Report. I was “foolish” enough to believe the threat of a malpractice suit was enough to keep doctors and hospitals on the straight and narrow. I was “foolish” enough to believe human beings could never be used as guinea pigs in the United States of America. Without a doubt, my “foolishness” hastened my mother’s death.
I had an ablation procedure done 3 years ago at Johns Hopkins, by Dr. Calkins. It went fine and to date I have had no recurrence of afib, so am very happy.
I’m glad for you. Do you know for a fact that Calkins actually performed the procedure–or did you just take his word for it?
We found out the hard way that trusting Hugh Calkins can be a dangerous thing to do.
My mother is in her 90′s now but when she was a young woman and an RN in Baltimore, her poor and indigent patients told her that Hopkins was not the hospital to go to if you wanted to get out alive. So local residents were very aware that learning on poor patients was accepted at Hopkins and undesired outcomes very common.
Thanks for the post. Have you read
The Immortal Life of Henrietta Lacks ?
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Yes, I did read it and it was very upsetting. I synopsized it for my mom (she has macular degeneration) and she was disgusted by it, but not at all surprised. Hopkins certainly has a tradition of cultivating doctors with god complexes. Combine that with racism and classism and patients are at high risk for poor outcomes.
Did you read the book? Yes they snipped her cancer and grew it, but they also took very good care of Henrietta. If she hadn’t neglected her tumor herself, her outcome may have been much much better. Then again, she had an unusually aggressive cancer and may have died regardless. Either way, she was treated as well as any other patient, even to the point of her final pain medications. The issue is now that her family wants a part of whatever profits were made from using HeLa cells in research, claiming they were her property, and therefore the heirs’. But to be real, her cells were of no value to anyone unless they were harvested and successfully cloned in a lab using newly developed techniques that had nothing to do with her relatives.
In the interest of full disclosure, where do you work?
I work for myself.
Dan,
I am so glad to see that you are still fighting Calkins and Johns Hopkins. I hope you win your appeal.
There is no way I would enter Johns Hopkins or let Calkins work on my heart.
I have had three Catheter Ablations and also the MAZE open heart surgery at the best place in the U.S, which is the Cleveland Clinic,and yet I still have Atrial Fibrillation. It is not an easy condition to cure. The physicians at the Clinic are absolutely first class and are present from the time you enter the Cath Lab until you are returned to your room. There is none of that Calkins Crap, using low-paid residents, allowed.
The Clinic’s Steve Nissen is a breath of fresh air blowing through the stink of the various bribes offered to doctors by heart equipment manufacturers.
Outstanding and a must read for anyone over 40 or anyone who is contemplating surgery. A real eye opener to say the very least. I am on my third reading and unfortunately have had the book (electronic version) corrupt on me. Trying to figure out how to get it back now.
Study Finds Conflicts Among Panels’ Doctors
nytimes.com/2011/03/29/health/29ethics.html
Hearings on Patient Safety Bill in Maryland House of Delegates: http://www.youtube.com/watch?v=Sk3nN2Xt2i4
Nice piece by By Liz Hollis and Erica Teichert at fiercepharma.com/special-reports/top-10-pharma-ceo-salaries-2010
“Despite a year fraught with manufacturing issues and drug recalls, Johnson & Johnson CEO Bill Weldon takes the top spot, with $28.7 million in 2010 pay. And Novartis’ Daniel Vasella grabs the number two spot thanks to a lucrative golden handshake.”
A prime example of great PR in the Deseret News from Thursday, Feb. 10, 2011:
The headline alerts readers that “Racing, fluttering or sluggish pulse may be arrhythmia”
Luckily, if your pulse is sluggish there’s a solution: “The most common fix to heart rhythm problems is a procedure called an ablation. Ablations are done by inserting a catheter into specific areas on the body that then read the heartbeat… Ablations usually cure the problem all together. There are no incisions involved with an ablation and the patient can leave after a day or two with just a couple band-aids.”
Ablations usually cure the problem all together? A couple of band-aids?
No mention of the recent study showing a 29% success rate…
This announcement looks very similar to one we saw in a local paper here about a year ago, when a local hospital announced opening of their new EP lab and proudly welcomed a new EP physician to the local practice of cardiology. Apparently, theses news releases are all written by the suppliers of ablation equipment and the physicians they have trained. Incidentally, the new physician here had been trained by Dr. Richard Wu at UT Southwestern and his crispy new certification in EP was only 2 months old when he and his new equipment arrived here.
The press release you quoted makes it seem so straight- forward that if any heart’s rate is irregular, the cure is here. I hope those who really can benefit find the ‘cure’ they need and don’t become “Collateral Damage” while these new docs and equipment find their place in our medical communities.
I also have to ask: when in medical treatment have the PR people ever been concerned about effectiveness of a treatment? Statins? Mammograms? Antidepressants? Hormone Replacement Therapy? Vioxx? Avandia? Bloodletting?(I think this one stayed around for about 4000 years) Stents? Angiograms for everyone? It seems like patient research is even more important than medical/pharma research. As patients we have to use the medical research as tools to find what works for us, not as mandates for what must be done.
Several recent studies show that stents are equally effective as drugs. But doctors still recommend stents because they can make more money.
“Opening blocked arteries with balloon angioplasty and stents can save lives during a heart attack, but the invasive treatment offers little added value over heart drugs alone in patients first treated days and even weeks later.
Now a new analysis shows that avoiding stenting in stable late-presenting patients could result in a yearly savings of around $700 million in health care costs.
“What we have here is one of those cases where less is more,” says researcher Daniel B. Mark, MD, MPH, of Duke University Medical Center.”
from:
webmd.com/heart-disease/news/20090218/heart-attack-care-drugs-vs-stents
i had an ablation 2 years ago. it was more than i bargained for – the machine for the procedure had problems so i was out for twice as long as i was supposed to be out. the recovery was brutal in terms of the bruising and the anesthesia hangover. reading the article about the intern probing for a vein, etc made my skin crawl. that was me on the table, 2 years before. i had my procedure done at a ‘teaching’ hospital, so i’m sure a similar debacle happened. i felt out of sorts for probably 6 months. it did normalize the rhythm, however. but i never was counseled on the long term effectiveness. i guess my mistake for not asking that question. there is NO way i will go through that procedure again.
Thanks very much for the comment. Best wishes for NSR.
Dan
Here’s the latest from the world of Cardiology:
“New York, NY – Physicians and patients have little solid data on which to estimate the long-term risks of radiation from cardiac imaging, despite a recent surge in research and public attention on the link between imaging and cancer risks. As the number and range of cardiac imaging procedures continue to grow, so do fears about what all that radiation is doing to patients…”
The Heart.org
More comments from Hugh Calkins that are beyond “sobering” from Heartwire.org
The implications . . .
To heartwire, Calkins called these long-term results “sobering,” considering the investigators performing the ablation procedures are part of the group who pioneered the therapy. That said, these results are in line with other reports, he noted, and the procedure has improved since 2001-2002. These results are likely the worst-case outcomes, and better equipment, including the use of irrigated catheters and the increased use of the circumferential pulmonary vein isolation technique, would have a beneficial effect on the long-term outcomes of procedures performed in later years, he added.
Overall, Calkins said the findings should not be interpreted negatively considering that other issues need to be judged when assessing the merits of atrial fibrillation.
“It isn’t that catheter ablation doesn’t work,” he said. “This paper didn’t look at atrial-fibrillation burden, which is a quality-of-life issue. You might have a patient that was in afib all the time, and you do an ablation, and they have a recurrence three years down the road, but that patient is still as happy as a clam, and their quality of life is better. Looking at recurrence as a yes-or-no question doesn’t provide a full view of the benefit.”
Regarding anticoagulation, Calkins said clinicians should continue to follow the Heart Rhythm Society consensus document that advises the use of the CHADS2 score to guide long-term anticoagulation strategies, and not use ablation as the guiding factor in their decision.
this the full posting below from the cut and paste job. Dan, please note the 83% success at 1 yr, 81% at 2 yr, and 63 percent success in all patients at 5 years after the mean 2 procedures. each patient was on mean 3.5 anti-arrhythmic medications prior to first ablation procedure. so essentially a selection bias for patients who had not responded to drugs. also note the class 1 indication in AHA/ACC 2010 guideline update for AF ablation in patients who have failed one AA drug. what will be interesting is the 3000 patient CABANA trial where people are randomized to drug vs ablation powered for mortality….more to come in 5-7 yrs I guess:
Long-term results after catheter ablation for AF are decidedly mixed, according to the longest study yet to follow patients after the procedure. In a report in the Journal of the American College of Cardiology, Rukshen Weerasooriya and colleagues followed 100 patients treated at a French hospital for 5 years. After a single procedure, the rates of arrhythmia-free survival were 40% at 1 year, 37% at 2 years, and 29% at 5 years. Patients underwent a median of 2 procedures during the study period. Following the last catheter ablation procedure, the rates of arrhythmia-free survival were 87% at 1 year, 81% at 2 years, and 63% at 5 years. Three patients had cardiac tamponade requiring drainage during the procedure. Patients with long-standing persistent AF were more likely to have a recurrence than other patients.
Results in the real world may be even worse than those reported in the study since, the authors noted, their “study population was not representative of patients with AF at large, as it consisted predominantly of younger, healthier, nonobese patients with relatively smaller atria and paroxysmal or recent progression to persistent AF.”
The authors concluded: “Although most recurrences transpire over the first 6 to 12 months, a slow but steady decline in arrhythmia-free survival is noted thereafter, even after 3 or more years of apparent arrhythmia control. Such long-term follow-up data should be openly discussed with patients, factored into management decisions, and incorporated into cost-effectiveness models that assess the merits of an ablation approach.”
This post is republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site.
UPDATE
Most Recent Study of Afib Ablation…
It doesn’t work:
Study Finds Mixed Results
“Mixed Results” is way too euphemistic. A 29% success rate at 5 year follow-up and “Results in the real world may be even worse than those reported in the study…”
Yes, things are often quite different in the real world.
To heartwire, Hugh Calkins called these long-term results “sobering,” considering the investigators performing the ablation procedures are part of the group who pioneered the therapy.