Introduction
Rick Kidwell “… it’s like the theory of sharks being attracted to blood in the water”: JUH Magazine, June 1999, http://www.jhu.edu/jhumag/0699web/oncampus.html
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 … : PoliceOne.com, February 11, 2005, http://www.policeone.com/police-products/press-releases/99272/
one of the more common date rape drugs: Wikipedia http://en.wikipedia.org/wiki/Sedative
VERITAS
“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 http://www.vindicomeded.com/cmelc/tc_lecture.asp?rid=17208
The Procedure: “Ready for Prime Time”
Study Affirms Value of Non-Surgical Treatment for Arrhythmia: JHMI Press Release, Jan 9, 1999, http://esgweb1.nts.jhu.edu/press/1999/JANUARY1/990119.HTM; JHMI Newsfeed, 1999, http://www.hopkinsmedicine.org/hnf/hnf_951.htm
Finally a Way to get Rid of A-Fib: JHMI Press Release http://www.hopkinsmedicine.org/hmn/W03/medrounds.cfm
heartwire, August 31, 2005, http://www.theheart.org/article/546039.do
“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. http://www.cmaj.ca/cgi/content/full/179/4/342-b
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 http://eurheartj.oxfordjournals.org/content/22/22/2038.full.pdf+html
The Cat’s out of the Bag
Cynthia Tracy, Transcript, Circulatory System Devices Panel, V2, July 22, 1998, p118 http://www.fda.gov/OHRMS/DOCKETS/AC/98/transcpt/3442t2a.pdf
“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 http://www.ajconline.org/issues?issue_key=S0002-9149(00)X0105-1
The Bottom Line
Professor Calkins, consultant..: JAMA. 2010;303(4):333-340. doi:10.1001/jama.2009.2029
http://jama.ama-assn.org/cgi/content/full/303/4/333#AUTHINFO
TASER SEC Lawsuit …: http://www.glancylaw.com/pdf/TASER.pdf%20
More than 330 people haved died after being TASERed…: http://www.amnesty.org/en/news-and-updates/report/tasers-potentially-lethal-and-easy-abuse-20081216
Death by TASER Dziekanski Taser YouTube Canada: http://www.youtube.com/watch?v=05vuY-kqp9o
That was enough for Canadians…: TASERS in Medicine http://ecmaj.ca/cgi/content/full/178/11/1401
The Alive or Dead Thing
Chilli catheter approval…: http://www.accessdata.fda.gov/cdrh_docs/pdf/P980003a.pdf
Assets Calkins…: http://67.192.184.241/assets/files/calkins-prospective-comparision-of-lesions.pdf
Cardima Revelation Dog Studies http://67.192.184.241/assets/files/calkins-prospective-comparision-of-lesions.pdf
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 http://dx.doi.org/10.1111/j.1540-8167.1994.tb01126.x
And Yes I sais Yes I Will Yes
A perfunctory signing of a consent form..: http://www.forensic-psych.com/articles/artMedicalNegligence.php
A Dangerous Instrument
“We are missing a lot of things at this point …” heartwire, August 2005 http://www.theheart.org/article/546039.do
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 http://onlinelibrary.wiley.com/doi/10.1002/ccd.v61:2/issuetoc
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 http://www.thefreelibrary.com/Cardima 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 http://www.thefreelibrary.com/Cardima 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 http://www.thefreelibrary.com/Cardima Announces Fourth Quarter and Full-Year Financial Results;…-a071123814
Breakthrough
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,
http://www.accessmylibrary.com/coms2/summary_0286-28402192_ITM
“the doctor put the catheder in my groin ..”: http://forums.wrongdiagnosis.com/showthread.php?t=8584
“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 http://www.fredlaw.com/bios/attorneys/klepinskirobert/Klepinski_JMDRMay2009.pdf
Ochoa was the company’s Regulatory Affairs Specialist who worked to get Haisseguerre’s new Lasso catheter…: Lasso 510k Approval http://www.accessdata.fda.gov/cdrh_docs/pdf/K002333.pdf
FDA 510k letter: The “standard Cordis Webster Diagnostic 7F Deflectable Catheter.” http://www.accessdata.fda.gov/cdrh_docs/pdf/K953663.pdf
Drawing, Webster Catheter United States Patent US4960134:http://www.freepatentsonline.com/4960134.pdf
“ doctors at Harvard would publish a paper” about Lasso catheter entrapment : http://www.ncbi.nlm.nih.gov/pubmed/15851219
“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…” http://tinyurl.com/CalkinsFDAProRhythm
“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 http://www.vindicomeded.com/cmelc/tc_lecture.asp?rid=17208
“Just another risk to put on the consent form,” ibid
“In some ways, EPs are operating blind… ”: http://www.theheart.org/article/116103.do
Calkins, Xray radiation Burns http://onlinelibrary.wiley.com/doi/10.1111/j.1540-8159.1997.tb03574.x/abstract
“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”: http://www.jhintl.net/forphysicians/default.aspx?id=3334
“but he has more sobering news …” http://www.cardiosource.com/expertopinions/hottopics/article.asp?paperID=228
““The true efficacy of Afib ablation remains unknown.”: Nature Reviews Cardiology 4, 4-5 (January 2007) doi:10.1038/ncpcardio0741 http://www.nature.com/nrcardio/journal/v4/n1/full/ncpcardio0741.html
“Calkins went on to say” … http://www.medicalnewstoday.com/medicalnews.php?newsid=50308
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, http://journals.lww.com/cardiologyinreview/toc/2001/05000
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 http://onlinelibrary.wiley.com/doi/10.1111/j.1540-8167.2008.01181.x/full
“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 http://cvm.controlled-trials.com/content/2/2/067 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: http://www3.interscience.wiley.com/cgi-bin/fulltext/118959025/PDFSTART
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 http://www.theheart.org/article/116103/cite.do
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 http://prod.nejm.org/doi/full/10.1056/NEJM199207303270504#t=articleTop
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 http://findarticles.com/p/articles/mi_qn4183/is_20060317/ai_n16143147/
The inspection turned up a number a irregularities and violations: http://www.circare.org/fdawls2/stimsoft_20031027.pdf
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.. http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3954t1.htm
How important is it for doctors to be careful with study data?http://content.onlinejacc.org/cgi/content/full/52/14/1111
“I had an ablation over 3 months ago ….” http://www.medhelp.org/posts/Heart-Disease/Chest-pain-following-ablation/show/10257
A Drink of Water
A Remedy of Errors: http://www.hopkinsmedicine.org/hmn/S04/feature1.cfm
a rare display of pique by the FDA… : http://www.fda.gov/ora/frequent/483s/JohnHopkins483.html
The FDA cited lack of informed consent… : http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM064075.pdf
Two Months Later
“Serious underlying problems that could compromise the quality of mammography performed at your facility, they represent a violation of the law”: http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/2001/UCM078215.pdf
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 http://www.nejm.org/toc/nejm/342/13/
“Johns Hopkins Admits Scientist used Indian Patients as Guinea Pigs” British Medical Journal, Nov. 2001 http://www.circare.org/im/im13Aug2002.htm
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…: http://www.uiowa.edu/~cyberlaw/hsr/hsrepilo.html
“The February 2002 issue of JHU Magazine: http://www.jhu.edu/jhumag/0202web/trials.html
introducing a bill that would shed some light on the whole human research situation…:http://mlis.state.md.us/2002rs/billfile/hb0917.htm
Physics Today reported in 2009 that Johns Hopkins University was the biggest recipient of US R&D funds…:http://physicstoday.org/
“It was a good thing for Hopkins, Inc…”: M. Alexander Otto BNA’s Medical Research Law & Policy Report, May 7, 2003 http://www.circare.org/bna05072003.pdf
Hopkins vice president Joanne Pollak told the Baltimore Sun: http://articles.baltimoresun.com/2002-03-15/news/0203150291_1_johns-hopkins-hopkins-medicine-research
Fine Wood Furniture
But he was a hard man to get a hold of, and an article in The American Medical News… http://www.ama-assn.org/amednews/2003/09/15/prsc0915.htm
“The council’s rebuke had no impact. Johns Hopkins Magazine dutifully reported that “Nine days into …”: http://www.jhu.edu/jhumag/1103web/wholly.html
Johns Hopkins Penalized for Resident Hour Violations
http://www.ama-assn.org/amednews/2003/09/15/prsc0915.htm
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 http://news.nurse.com/apps/pbcs.dll/article?AID=2002204120307
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 http://www.vindicomeded.com/cmelc/tc_lecture.asp?rid=17208
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…”:http://oig.hhs.gov/publications/docs/press/2003/021403release.pdf
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) http://jama.ama-assn.org/cgi/content/full/303/4/333
Larry Husten “Let’s be clear,”: http://www.kevinmd.com/blog/2010/02/treating-atrial-fibrillation-catheter-ablation-tv-ethical.html
Collateral Damage: A Patient, a New Procedure and the Learning Curve 