United States Attorney Michael J. Sullivan and Kim A. Rice, Special Agent in Charge of the Food and Drug Administration's Office of Criminal Investigations, Metro Washington Field Office, announced today that ANNE BUTKOVITZ, age 48, of Newton, Massachusetts, was sentenced by U.S. District Judge Douglas P. Woodlock to 1 year of probation and a $1,000 fine. BUTKOVITZ pleaded guilty on June 7, 2005, to an Information charging her with one count of making false statements. As part of her plea agreement with the Government, BUTKOVITZ also agreed that she would never participate in any manner in the conduct of studies intended for or required for submission to the FDA.
At the earlier plea hearing, the prosecutor told the Court that, had the case proceeded to trial, the evidence would have proven that in May, 2001, BUTKOVITZ became the clinical study coordinator at a pediatric practice for a pharmaceutical company's clinical trial entitled "Safety and Efficacy of Pentavalent (G1, G2, G3 G4 and P1) or Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants." The objective of the study was to evaluate the efficacy and safety of the pharmaceutical company's rotavirus vaccine against rotavirus disease in children. Rotavirus causes severe diarrhea in infants. A similar rotavirus vaccine marketed by another pharmaceutical company had previously been discontinued due to concerns that it caused intussusception, also known as blocked bowel syndrome.
According to the clinical study protocol to evaluate safety, all study subjects were followed after each vaccine dose for all serious adverse experiences ("SAEs"), including intussusception. To determine if SAEs occurred, the study protocol required the study site to contact the subject's parent(s) at three intervals after each of the three vaccinations. At the time of each contact, the study site was required to indicate on a Case Report Form whether contact was made, the date of contact and responses to a series of questions.
In her role as the clinical study coordinator, BUTKOVITZ was responsible for, among other things, making all follow-up contacts with the study subjects as required by the clinical study protocol. It is alleged that BUTKOVITZ did not make the required contacts with parents/guardians of the clinical study yet falsely stated on the Case Report Forms that she had made the contacts.
BUTKOVITZ was specifically charged with making false statements on September 25, 2002, in connection with the clinical study by falsely representing that she had received certain information regarding the "serious adverse experiences" of a patient in the clinical study.
After learning that BUTKOVITZ had not made the safety contacts required by the protocols of the clinical study, on February 5, 2003, the pharmaceutical company removed the pediatric practice and the data it had generated from the study.
The case was investigated by the Food and Drug Administration's Office of Criminal Investigations. It was prosecuted by Assistant U.S. Attorney Jeremy Sternberg in Sullivan's Health Care Fraud Unit.
Source: U.S. Attorney
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