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Doctor Barred from Pacemaker Research on Humans

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At a glance:

The FDA has barred a University of Arizona cardiologist from conducting research using human subjects. 
 
Dr. Paul Fenster was found to have violated rules protecting patient safety after his own University reported him to the FDA. 
 
The research involved implanted Guidant heart pacemakers. 
 
Breaches of rules included using doctors and patients who were not approved or eligible, respectively, for the study; not keeping accurate records; and not reporting deaths or other "adverse effects" to the FDA as required. 
 
Dr. Fenster maintains his research is valid and the errors were "clerical".

UA doctor barred from research on humans

Tucson Citizen - 5/31/2006 11:11 AM

A University of Arizona cardiologist has been permanently barred from conducting medical research on humans after the Food and Drug Administration found serious violations by him of federal rules that protect patient safety.
 
The cardiologist's research involved implanting a biventricular pacemaker device in individuals with serious heart disease.
 
"It's hard to say who was harmed and how," said Leslie Tolbert, UA's vice president for research, graduate studies and economic development. "He was following practices that didn't minimize the protection from harm. You can't just say, 'I know my patient will be okay. This is fine.'
 
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