The FDA has announced that a coordinator at a pediatric practice involved in an FDA approved clinical study has been charged with falsifying data with respect to follow up contact information she was supposed to obtain directly from the parents of children vaccinated with an experimental rotavirus vaccine. Rotavirus causes severe diarrhea in infants.
The woman, Anne Butkovitz, worked as the clinical study coordinator at the pediatric practice enrolled in the study and was responsible for required follow-up contacts with the parents of the children after each of three vaccinations. The purpose of the follow-ups was to determine if there had been any serious adverse experiences (SAEs). It is alleged that Ms. Butkovitz did not make the required contacts and yet claimed that she had on report forms. In one case, she is accused of having actually falsified information with respect to the SAEs of a patient enrolled in the clinical study.
As a result of Ms. ButkovitzÃs actions, the pharmaceutical company involved removed the pediatric practice she was employed by from the study and disregarded the data it had generated.