editing …
(In the medical literature, Hugh Calkins always confirms what Jeff Brinker wrote in 1991 http://circ.ahajournals.org/cgi/reprint/84/5/2213 about cardiac catheterization in general: The experience and knowledge of the performing physician are critical, as are the experience and teamwork of laboratory personnel.)
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Complaint MD Physicians http://wp.me/PcIjX-d
Behind closed doors http://wp.me/PcIjX-
Addendum http://wp.me/PcIjX-be
Citations (fragment) http://wp.me/PcIjX-VY
Patient Combative
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“I think I’m going to die”
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Medical experiment disclosure hinges on a flawed honor system Hopkins worker death raises wider questions.
By Tom Pelton, Sun Staff, August 12, 2001
Problems at Hopkins
Dr. Greg Koski, director of the federal Office of Human Research Protections, said he doesn’t know how accurate Shamoo’s figures might be, but he acknowledges that the underreporting of “adverse events” could be a problem. Koski’s agency recently suspended most experiments at Johns Hopkins when it found systemic problems with the review of experiments after the death June 2 of volunteer Ellen Roche.
Koski said his agency will work with the National Institute of Health and the Food and Drug Administration this fall to improve the national system for monitoring experiments and collecting and sharing reports of deaths and injuries. “It’s difficult to know how much is underreported,” Koski said. “Many of these adverse events are being handled at the local level, and I don’t know if they are being handled in the optimal way. There is no question that there is room for improvement.” Koski added, however, that federal law does not require researchers to report all injuries and deaths among study subjects to his agency.
It requires reports only of regulatory violations and health problems that are unexpected and likely a result of the treatment. The agency leaves it up to researchers and university review boards to sort through the sticky problem of separating which health problems are a product of illnesses and which are side effects of the drugs. Koski’s agency, with only 45 employees, would be overwhelmed with paperwork if every research institution in the United States sent in every report of problems in the thousands of federally funded experiments across the country, said Bill Hall, a spokesman for the agency.
The number of incident reports flowing into the agency has almost tripled in recent years, rising from 100 in 1997 to 290 in 2000, with at least a third of these detailing unexpected health problems suffered by volunteers, according to the agency. The increase stems from increasing awareness of federal reporting requirements and a surging amont of medical research, Koski said. In contrast to Johns Hopkins, the University of Maryland released its adverse-events numbers when asked by The Sun.
The review boards that monitor experiments at the university’s medical school received 880 reports of “serious adverse events” to volunteers during more than 1,000 experiments last year. The university defines “serious adverse events” as “any untoward medical outcome occurring in the context of research” – which could include anything from vomiting to the deaths of seriously ill cancer or cardiac patients, according to school spokesman Larry Roberts.
The majority of these health problems, in 728 cases, were judged to be unrelated to the studies – for example, volunteers injured in car accidents while away from the hospital, Roberts said. The university reported only two cases to the federal agency because they were the only cases that were unexpected and probably linked to the treatment, and not to an underlying illness, Roberts said. One was a blood infection that a researcher mistakenly gave to a 24-year-old volunteer in a metabolism study.
Another was the death of a 61-year-old man with life-threatening heart disease who may have suffered a reaction to medications he was taking in a study, Roberts said. The Johns Hopkins University, unlike Maryland, refused to release information about the number of problems suffered by volunteers in its more than 2,700 experiments last year. Joann Rogers, a spokeswoman for Hopkins, said the university has no evidence of widespread problems with underreporting.
“We are looking to see if there are systemic problems,” Rogers said. “If there are, we are going to do whatever it takes to change that.” Shamoo and others complain that self-policing invites a lack of candor. “It’s an honor system,” said Arthur Caplan, director of the University of Pennsylvania’s Bioethics Program. “Many adverse events do not get reported because doctors and researchers don’t like to think about themselves causing harm. So if there’s something else to blame it on, like an illness, they will.”
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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=623585
(Notes: 2003 calkins sez 80% success rate. Check this put real figures after the graph.
Consent Forms:
Accepting the fact that Pam signed a standard consent form in the stressful moments before the procedure, the form contains no such language as is offered at other hospitals:
I authorize Dr. ____________, and such physicians in training and assistants as (s)he may select, to treat my condition… I UNDERSTAND THAT PHYSICIANS IN TRAINING MAY PERFORM PORTIONS OF THE PROCEDURES DESCRIBED BELOW …” (Emphasis Original) University of Virgina Health System.
Contrary to professional guidelines, the form at Hopkins makes no mention of the specific involvement of a trainee in the procedure. A barely legible scrawl of the word “staff” can hardly be considered full, comprehensive and specific material information.
I hereby give my consent and authorize Doctor ___Calkins/staff____of the Johns Hopkins Hospital to perform the following operation or other procedure: ELECTROPHYSIOLOGY TESTING AND ABLATION
One could be forgiven for thinking that since the person who proposed and explained the procedure was Hugh Calkins, and that Hugh Calkins made clear that operator experience is essential to minimize risks and insure success, and that Hugh Calkins made clear that he – Hugh Calkins – was just the experienced professional operator needed in this situation, well one could be forgiven for making the ordinary assumption that /staff meant nurses and technicians and the like.
“A perfunctory, signing of a consent form elicits mere passive assent, not active consent. It neither enhances patient understanding nor helps the patient take responsibility for his or her choices. There is a substantial consensus in our society that it is unethical to impose risks on people without their consent.” – Dr. Harold J. Bursztajn, Associate Clinical Professor and Co-Director, Program in Psychiatry and the Law, Harvard Medical School.
“Few Decisions bespeak greater trust and confidence than the decision of the patient to proceed with surgery. Implicit in that decision is a willingness of the patient to put his life or her life in the hands of a known and trusted medical doctor… the doctor who, without the consent of the patient, permits another surgeon to operate violates not only a fundamental tenet of the medical profession, but also a legal obligation.” Supreme Court of New Jersey 92 N.J. at 463-465, 457 A.2d at 440-441.
Disclosure
“Hugh Calkins, MD, FACC, FAHA, FHRS, has disclosed that he has served as a consultant to ProRhythm, Ablation Frontiers, CryoCor, and Biosense Webster. Dr. Calkins has also disclosed that he has served as a speaker for Biosense Webster and Reliant” http://www.medscape.com/viewprogram/7535_authors
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“Uh… You Weren’t There That Day”
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Risk Management: “You’ll Get Nothing!”
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The Wilmer Eye Center on Scratched Corneas: “Oh, we see a lot of that in the ICU.”
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http://www.theheart.org/article/546039.do
Here is some mind-bending logic:
Experts say time has come for AF ablation RCTs: “Only thing missing is the data”
August, 2005
“We’re missing a lot of things at this point,” Dr Hugh Calkins (Johns Hopkins University Medical Center, Baltimore, MD) told heartwire. “Everything is based on, ‘This is how I think my patients are doing.’ If history holds true, the results are always worse when the procedure is held up to a multicenter, rigorous study, where you prospectively define the complications and evaluate. We need better data on the true efficacy and safety of the procedure in patients selected as part of a multicenter study in a rigorous, prospective fashion.”
Dr Andrea Natale, medical director for the Center for Atrial Fibrillation at the Cleveland Clinic, told heartwire that the center performs five to six AF ablations every day and that the waiting list extends from anywhere between four and nine months. Smaller centers perform fewer procedures, and their success and complication rates vary, he noted.
“Atrial fibrillation ablation is technically very challenging,” he said. “This is the deterrent for less skilled hands in embracing the procedure.”
| st 31, 2005 |  |
Michael n |
Calkins predicts that there is probably a two- to five-year horizon before ablation of AF is a primary therapy. “Some doctors are pretty enthusiastic about ablation as a primary therapy, but they’re only enthusiastic until a patient has a stroke or some type of devastating consequence. Then the enthusiasm tends to go down a little bit,” he notes.
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Kim,
Were you ever able to pin that lying little weasel Hugh Calkins down about his complication rate?
Thank You,
Dan Walter
Dan Walter wrote:
Kim Young wrote:
Dear Sir,
Thank you for your comments about an article on Cardiosource by Dr. Hugh
Calkins, Atrial Fibrillation: Drugs or Ablation. From your coments, it seems as
though your issue is with Dr. Calkins, and I recommend that you get in touch
with him directly. We are, however, seeking to get clarification of the
statement in question and will modify the paragraph accordingly. In the
paragraph above the one quoted by you (see below) Dr. Calkins states that the
complication rate for the procedure is 6%. This is clearly inconsistent with
his next comment of “one-in-a-thousand”. We will ask Dr. Calkins to clarify
this inconsistency for us , and correct it on the site.
Sincerely,
Kim Young
Senior Editor, Cardiosource
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The Records
http://well.blogs.nytimes.com/2008/06/27/the-growing-disconnect-between-doctors-and-patients/
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84.
Dan Walter (79) brings up an interesting point. I happen to be a “research doctor” and Electrophysiogist (a Cardiologist who studies the electrical properties of the heart).
I agree that there is intellectual and ethical tension inherent in clinical and basic science research. On one hand, patients have a right to get care which is shown to be efficacious and safe. The entire concept of research has evolved because in the not-so distant past, treatments were based on “good ideas” rather than solid evidence. On the other hand, in order to demonstrate clinical efficacy, one needs to perform clinical research.
There is no doubt that some researchers become so invested in their trials that they lose sight of the best interest of the individual patient. This is unacceptable. I personally meet with each patient enrolled in the study, assure them that there are alternatives to my research, and let hem know that they are entitled to receive the standard of care treatment without exception if they wish.However, the excerpt you quote from the ACC/AHA guidelines misses your point entirely, and is out of context. The quoted text refers to an ongoing debate regarding education, not clinical research. The admonition is akin to reminding conservatory students that it is the music, not the recording technology, that makes their calling special.
Further, the author of the quote, a well known “research” physician” in a Boston “research hospital,” is famous for putting the individual patient above all else.
We cannot provide patients with the care they deserve and demand without responsible clinical research.
— Posted by Mike
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85.
Dear Dan (79),
I just read your touching account of your wife’s ordeal. You have effectively captured an aspect of interventional cardiology and critical care medicine which we all wish did not exist. My heart goes out to you and your family, and you are in my prayers.
My only hope is that the “lesson learned” by myself and my interventional minded colleagues is not just one of technique, but one of humility and honesty; we all (surgeons, physicians, and someties patients) tend to minimize, and sometimes forget completely, the audacity of what we are trying to do: namely, stop or alter completely a biologic process which has been evolving at least as long as we have been. When you think about it, we should be suprised that it works at all. We definitely have a long way to go.Again, you are in my thoughts and prayers.
— Posted by Mike
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112.
Dear Mike (#84)
Thanks for your comments on my story. It is very important to me that I get it right and I am curious to know more about your feelings on the AHA/ACC quote about EP technology:
“… Although it is exciting, it should be kept in mind that the technology facilitates the application of those fundamental principles of Electrophysiology only for the benefit of arrhythmia patients.”
I do not think I am misreading this. It appears to me to be a caution to physicians that although this new technology (enhanced catheter ablation techniques for AFIB) is fascinating – don’t forget that is being developed for the good of the patient. The fact that “the author of the quote… is famous for putting the individual patient above all else.” would seem support my interpretation. Im not sure I understand the music analogy – aside from as it applies to patient safety.
I would really appreciate your thoughts.
— Posted by Dan Walter
- y 2nd,
2008
5:49 pm
Dear Dan, (79);
I apologize for mischaracterizing your quotation of the ACC guideline in your original comment (79). After reading your post, I assumed you were referring to the guidelines as pertaining to EP clinical research. After reading your account of your wife’s ordeal, I understand that your quote sums up your point beautifully. There is a small but increasingly vocal movement in EP and interventional cardiology which calls for restraint and reason in practice, particularly in a field where technologic advancement is so rapid.
There is also an ever present paradox in procedure-driven fields which require intense training at well known academic centers; both the patients and the trainees go there for access to high profile practitioners. Institutions and physicians must constantly balance the care of the patient with the training of the next great, for example, electrophysiologist. As a result, all patients at these centers need to know, that 1)trainees may be involved in their care; and 2) theyhave a right to limit a trainee’s involvement if they choose.
The best situation is when the trainee/fellow is involved all aspects of care-the consult, the office visit, the consent, and the follow up. It is always better to get to know the family as well-after all, this is what the the rest of their career will be like.
When you get to know a patient, you tend to think of them (’how can I reduce this person’s risk and make their life better?’) before yourself (’what new technique can I try out on this patient today?’). I am convinced that this approach has led me to choose wisely, and has saved more than couple patients from complications.
— Posted by Mike (84, 85)
Tate Stillwell 
Collateral Damage: A Patient, a New Procedure and the Learning Curve 
2008
5:49 pm
Dear Dan, (79);
I apologize for mischaracterizing your quotation of the ACC guideline in your original comment (79). After reading your post, I assumed you were referring to the guidelines as pertaining to EP clinical research. After reading your account of your wife’s ordeal, I understand that your quote sums up your point beautifully. There is a small but increasingly vocal movement in EP and interventional cardiology which calls for restraint and reason in practice, particularly in a field where technologic advancement is so rapid.
There is also an ever present paradox in procedure-driven fields which require intense training at well known academic centers; both the patients and the trainees go there for access to high profile practitioners. Institutions and physicians must constantly balance the care of the patient with the training of the next great, for example, electrophysiologist. As a result, all patients at these centers need to know, that 1)trainees may be involved in their care; and 2) theyhave a right to limit a trainee’s involvement if they choose.
The best situation is when the trainee/fellow is involved all aspects of care-the consult, the office visit, the consent, and the follow up. It is always better to get to know the family as well-after all, this is what the the rest of their career will be like.
When you get to know a patient, you tend to think of them (’how can I reduce this person’s risk and make their life better?’) before yourself (’what new technique can I try out on this patient today?’). I am convinced that this approach has led me to choose wisely, and has saved more than couple patients from complications.
— Posted by Mike (84, 85)