(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.)
Complaint MD Physicians http://wp.me/PcIjX-d
Behind closed doors http://wp.me/PcIjX-
Citations (fragment) http://wp.me/PcIjX-VY
“I think I’m going to die”
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.”
(Notes: 2003 calkins sez 80% success rate. Check this put real figures after the graph.
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.
“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
“Uh… You Weren’t There That Day”
Risk Management: “You’ll Get Nothing!”
The Wilmer Eye Center on Scratched Corneas: “Oh, we see a lot of that in the ICU.”
Here is some mind-bending logic:
Experts say time has come for AF ablation RCTs: “Only thing missing is the data”
“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.
Were you ever able to pin that lying little weasel Hugh Calkins down about his complication rate?
Dan Walter wrote:
Kim Young wrote:
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.
Senior Editor, Cardiosource