Source Notes


Rick Kidwell “… it’s like the theory of sharks being attracted to blood in the water”: JUH Magazine, June 1999,

A Mitral valve,  Flapping in the Breeze, Prolapsed into the Atrium…

“Doctors love to patronize and dominate…”: Issues in Medical Ethics Volume 8, Number 4, October-December 2000

“the attending shows up to be there during the burn.”: Transcript, FDA Circulatory  Systems Devices Panel meeting May 29, 2003

out selling TASER guns … :, February 11, 2005,

one of the more common date rape drugs: Wikipedia


“The fact that this procedure was performed at a teaching hospital is not relevant…” Ward Ethics, Kushner, Thomasma, Cambridge University Press, 2001 The Responsibility of Informing, p 23

He was experimenting with two new ablation techniques and testing out a couple of new mapping catheters…: Transcript, Ablation Strategies for Management of Atrial Fibrillation, Lecture with Slides Hugh Calkins, MD

The Procedure: “Ready for Prime Time”

Study Affirms Value of Non-Surgical Treatment for Arrhythmia: JHMI Press Release, Jan 9, 1999,;  JHMI  Newsfeed,  1999,

Finally a Way to get Rid of A-Fib: JHMI Press Release

heartwire, August 31, 2005,

“Delay Would be Dangerous, Potentially Catastrophic”

Professor Luceri, who would later join Hugh Calkins… :  Canadian Medical Association Journal CMAJ August 12, 2008; 179 (4). doi:10.1503/cmaj.1080079.

Progress continues in the quest to cure atrial fibrillation with catheter ablation techniques…”: Eur Heart J (2001) 22(22): 2038-2040 doi:10.1053/euhj.2001.2757  H. Calkins

The Cat’s out of the Bag

Cynthia Tracy, Transcript, Circulatory System Devices Panel, V2, July 22, 1998, p118

“Just because we can doesn’t mean we should…”:

Transcript, Circulatory System Devices Panel, V2, July 22, 1998, ibid p118

Vetrovec I’ll tell you how... ibid p 188

A  New System for Catheter Ablation …:

A New System for Catheter Ablation of Atrial Fibrillation American Journal of Cardiology Pages 227-236, 11 March 1999

The Bottom Line

Professor Calkins, consultant..:  JAMA. 2010;303(4):333-340. doi:10.1001/jama.2009.2029

TASER SEC Lawsuit …:

More than 330 people haved died after being TASERed…:

Death by TASER Dziekanski Taser YouTube Canada:

That was enough for Canadians…: TASERS in Medicine

The Alive or Dead Thing

Chilli catheter approval…:

Assets Calkins…:

Cardima Revelation Dog Studies

Chill ablation study:..: Catheter Ablation of Ventricular Tachycardia in Patients With Structural Heart Disease Using Cooled Radiofrequency Energy…: Journal of the American College of Cardiology
Volume 35, Issue 7, June 2000, Pages 1905-1914

Learning by Burning…: MARCHLINSKI, FRANCIS E. Insights into the Electrophysiology of Ventricular Tachycardia Gained by the Catheter Ablation Experience: Journal of Cardiovascular Electrophysiology 1994,Vol.5 DO  – 10.1111/j.1540-8167.1994.tb01126.x

And Yes I sais Yes I Will Yes

A perfunctory signing of a consent form..:

A Dangerous Instrument

“We are missing a lot of things at this point …” heartwire, August 2005

Presentations, Papers and Posters

Competition for technology…: Ethical Issues for Invasive Cardiologists:Catheterization and Cardiovascular Interventions Volume 61, Issue 2, pages 157–162, February 2004

A hot night in Dixie…: (1998, November 12). Cardima Holds Annual Arrhythmia Symposium and Launches New Website at American Heart Association Meeting in Dallas The Free Library. (1998). Retrieved November 29, 2010 from Holds Annual Arrhythmia Symposium and Launches New Website at…-a053207967

Berger Pathfinder…:(1998, April 3). Cardima Successfully Treats First Patient in United States Atrial Fibrillation Study at the Johns Hopkins Hospital The Free Library. (1998). Retrieved November 29, 2010 from Successfully Treats First Patient in United States Atrial…-a020454690
Cardima… his company just posted a first quarter loss of nearly  $4 million…: (2001, February 7). Cardima Announces Fourth Quarter and Full-Year Financial Results; Monthly Burn Rate Cut to Approximately $600,000 as Company Focuses on Phase III Clinical Trial for Atrial Fibrillation The Free Library. (2001). Retrieved November 29, 2010 from Announces Fourth Quarter and Full-Year Financial Results;…-a071123814


Haisseguerre “Electrophysiological Breakthroughs From the Left Atrium to the Pulmonary Veins” Circulation. 2000 Nov 14;102(20):2463-5.

Calkins “…he himself had all but abandoned the idea. Citing data from 1998”:  Calkins, a Practical Approach to Catheter Ablation for Atrial Fibrillation , Lippincott Williams & Wilkins, 2008

PR Newswire, “Patient was a 68 year old female … ”: Cardima pres release,

the doctor put the catheder in my groin ..”:

“One can easily see how this can increase the number of approvals…”: Kelpinski  Robert J. Klepinski, Journal of Medical Device Regulation, 2009, 6 (2), 8-19

Ochoa was the company’s Regulatory Affairs Specialist who worked to get Haisseguerre’s new Lasso catheter…: Lasso 510k Approval

FDA 510k letter: The “standard Cordis Webster Diagnostic 7F Deflectable Catheter.”

Drawing, Webster Catheter United States Patent US4960134:

“ doctors at Harvard would publish a paper”  about Lasso catheter entrapment :

“Do We Know What We’re Doing?”

Calkins:  “I think all of us are aware of the fact that the published literature probably tremendously overestimates the true efficacy of catheter ablation…”

“A typical case is someone who had pulmonary vein ablation shows up in the ER…”: Transcript, Ablation Strategies for Management of Atrial Fibrillation, Lecture with Slides Hugh Calkins, MD

“Just another risk to put on the consent form,” ibid

“In some ways, EPs are operating blind… ”:

Calkins, Xray radiation Burns

“Visualization of the catheter tip in relation to the cardiac anatomy is crucial.”: Medical Clinics of North America. P476 Vol 85 No. 2, March 2001

“The Arrival of A-FIB Ablation”:

“but he has more sobering news …”

““The true efficacy of Afib ablation remains unknown.”: Nature Reviews Cardiology 4, 4-5 (January 2007) doi:10.1038/ncpcardio0741

“Calkins went on to say” …

The Ideal Candidate

“There are many areas in which there can be a conflict between the patient’s best interest and the physician’s own personal interest….

Calkins: “catheter ablation of AF should be considered to be an experimental procedure.”: of Cardiac Arrhythmias  Cardiology in Review: May/June 2001 – Volume 9 – Issue 3 – pp 121-130,

Room for Improvement

In this study, we provide analysis of AF ablation complications for 641 consecutive procedures.”: Journal of Cardiovascular Electrophysiology, Vol. 19, Issue 6, pp 627–631, June 2008.DOI: 10.1111/j.1540-8167.2008.01181.x

“Patients were enrolled prospectively in a longitudinal patient database…”: ibid

Dr. Marcus Wharton  at the Medical University if South Carolina  posed a question…: Current Controlled Trials in Cardiovascular Medicine 1468-6708 2001 2 2 67 70 10.1186/cvm-2-2-067 11806775 6 3 2001 13 3 2001 5 4 2001 2001 BioMed Central Ltd ablation atrial fibrillation pulmonary veins

A Dangerous Instrument

Around the time that Pam became one of the first 100 unwitting participants…: Hindricks Kottkamp: * Potential Benefits Risks and Complications of Catheter Ablation for Atrial Fibrillation, More Questions than Answers. Published August 2002  Hindricks, Kottkamp 

J Cardiovasc Electrophysiol, Vol. 13, pp. 768-769, August 2002:

It’s Making Money for the Hospital

Gallagher, Gorden Tomassoni,and “Sonny” Jackman were interviewed about a catheter navigation system on the board at  Stereotaxis: heartwire

Dr. Jackman serves as a paid consultant to Webster Laboratories, the manufacturer of the catheters used for ablation in this study…. N Engl J Med 1992; 327:313-318

Just One of Those Things

Johns Hopkins University President William R. Brody decided that he wanted JHU to get a piece of the action. (Baltimore) Daily Record, March 17, 2006

The inspection turned up a number a irregularities and violations:

The Spin You Put on It

The process of obtaining informed consentfrom patients mandates…”  Roderick Tung J Am Coll Cardiol, 2008; 52:1111-1121, doi:10.1016/j.jacc.2008.05.058

“the safety and efficacy of pulmonary vein ablation was unknown  then [in 2000] and it is unknown now..

How important is it for doctors to be careful with study data?

I had an ablation over 3  months ago ….”

A Drink of Water

A Remedy of Errors:

a rare display of pique by the FDA… :

The FDA cited lack of informed consent… :


Two Months Later

“Serious underlying problems that could compromise the quality of mammography performed at your facility, they represent a violation of the law”:

another study that was even more similar to Tuskeegee…: Investigators’ Responsibilities for Human Subjects in Developing Countries, Angell, Marcia , N Engl J Med 2000; 342:967-969, March 30, 2000

“Johns Hopkins Admits Scientist used Indian Patients as Guinea Pigs” British Medical Journal, Nov. 2001

The Gravy Train

Letter from the Food and Drug Administration regarding unregulated human experimentation…:

Click to access bna05072003.pdf

The Baltimore Sun’s Tom Pelton wrote about voluntary oversight…:

“The February 2002 issue of JHU Magazine:

introducing a bill that would shed some light on the whole human research situation…:

Physics Today reported in 2009 that Johns Hopkins University was the biggest recipient of US  R&D funds…:

“It was a good thing for Hopkins, Inc…”: M. Alexander Otto BNA’s Medical Research Law & Policy Report, May 7, 2003

Hopkins vice president Joanne Pollak told the Baltimore Sun:

Fine Wood Furniture

But he was a hard man to get a hold of, and an article in The American Medical News…

“The council’s rebuke had no impact. Johns Hopkins Magazine dutifully reported that “Nine days into …”:

Johns Hopkins Penalized for Resident Hour Violations

Patient Combative

“Most critical care nurses are familiar with the term ICU psychosis,”: Brenda Hixon-Vermillion of  the Ohio State University Medical Center,  Nurseweek/Nursing Spectrum April 12, 2002

Not the Answer

“So really where I became enamored with Afib ablation..”: Transcript, Ablation Strategies for Management of Atrial Fibrillation, Lecture with Slides Hugh Calkins, MD

Hey, it Could Happen to Anyone

“I would de-scrub when it’s time to analyze the figures..”:Deposition, Hugh Calkins, Pam Walter v. Hugh Calkins, Johns Hopkins

“Johns Hopkins Medicine is already listed in the Federal Contractor Misconduct Database…”:

Read All  About It

“I can’t think of a procedure in the history of medicine…”: Dr. Doug A.  Morrison, Yakima, WA  Heart Center, Transcript, p175  FDA Circulatory Systems Device Advisory Panel, Sept. 20, 2007

Click to access 2007-4318t2-02.pdf

The lead article in the January, 2010 issue of the Journal of the American Medical Association, (Vol. 303, No.4)

Larry Husten “Let’s be clear,”:

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