Researcher Cited for Tardy Reporting of Patient Deaths

Clinical investigator David Vesole waited more than a month before reporting two patient deaths to the institutional review board (IRB) for drug studies he conducted while he was at the Medical College of Wisconsin in Milwaukee, according to an FDA warning letter.

The first death occurred Sept. 6, 2001, but was reported to the IRB Oct. 10, 2001, while the second occurred Nov. 5, 2002, and was reported to the IRB Dec. 12, 2002, according to the warning letter, which was sent to Vesole in care of his attorney, Kathy Nusslock. The letter was sent May 30 and posted recently to the agency website.

Vesole also failed to promptly report three other serious adverse events to the IRB and the sponsor, the warning letter said. One patient suffered from diarrhea Oct. 28, 2001, an incident that was reported to the sponsor July 20, 2002 and to the IRB July 22, 2002. A second patient suffered from abdominal pain Aug. 9, 2002, an incident that was reported to the sponsor and the IRB Nov. 4 of that year. A third patient experienced nausea and vomiting July 25, 2001, a fact that was reported to the sponsor Aug. 28, 2001, and to the IRB Oct. 25, 2001.

The warning letter is based on an inspection done between March 10 and April 6, 2006, which reviewed Vesole’s conduct of several drug trials. Vesole replied to a Form 483 issued after the inspection, but the warning letter said the FDA was not satisfied with the response, which he submitted through Nusslock May 18, 2006.

The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6407c.pdf.