CLINICAL INVESTIGATOR ACCUSED OF NOT EXAMINING SUBJECT HAVING HEART ATTACK

A clinical investigator failed to examine a subject who showed up for a scheduled study visit complaining of indigestion and turned out to be having a heart attack, according to a warning letter from the FDA.

The warning letter, which was sent to Herman Zaharowitz Sept. 14 and posted to the FDA's website Sept. 26, said when the subject came in for his 52nd study visit in August 2003, he did not receive a complete physical exam, as called for in the study protocol, and was seen by two nurses rather than the clinical investigator himself. The nurses took the subject's electrocardiograms (ECG), which showed "a machine reading of 'probable myocardial infarction,'" but neither the clinical investigator nor the study coordinators reviewed the ECG that day. The subject went to an emergency room three days later and had to have an angioplasty.

The warning letter also said Zaharowitz took several weeks to review some of the laboratory results for the study, a clinical trial of a gout drug. Moreover, a licensed practical nurse working for Zaharowitz did five of the physical exams for the study, although "only the principal investigator and subinvestigators (all physicians) were authorized to perform physical examinations" under the protocol, and "no other individuals listed were qualified to perform physical examinations without oversight by a physician." Finally, the warning letter said that Zaharowitz used outdated and expired versions of the informed consent form with some of the subjects.

Zaharowitz did not respond to a request for comment by press time. The warning letter can be accessed at www.fda.gov/cder/warn/2006/06-HFD-45-0803.pdf (http://www.fda.gov/cder/warn/2006/06-HFD-45-0803.pdf).