Cardiologist Cited for Informed Consent Failures

July 24, 2008

A cardiologist conducting a clinical trial failed to get informed consent, enrolled the same patient twice and did not maintain acceptable case histories and drug disposition records, an FDA warning letter says.

Edward Mostel of Palm Beach Gardens Medical Center in Florida started two patients in the trial before they signed informed consent forms, according to the warning letter, which was sent May 16 and posted to the FDA website this month.

Mostel replied that the forms may have been misdated, but the agency rejects his assertion as unprovable and added that a third patient’s consent form was not signed or dated by him or any subinvestigator.

Mostel acknowledged that a patient had been enrolled in the study twice but blamed the mistake on a subinvestigator, the warning letter says. The agency also notes that Mostel was responsible for overseeing the study as its clinical investigator.

During its investigation, conducted Oct. 17–31, 2007, the FDA found that drug accountability records were missing for nine subjects between Oct. 13 and Dec. 5, 2005, according to the letter. Mostel responded that hospital records confirmed the subjects received the study drug according to protocol, but the agency’s letter says he provided no evidence to support that assertion.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/s6838c.htm.