Clinical Study Coordinator for Pediatric Drug Charged With Fraud, Reports U.S. Attorney

BOSTON, May 25 /PRNewswire/ — A Newton woman was charged today in federal court with making false statements in connection with a Food and Drug Administration approved clinical study.

United States Attorney Michael J. Sullivan and Mark Dragonetti, Special Agent in Charge of the Food and Drug Administration in New England, announced today that ANNE BUTKOVITZ, age 47, of Newton, was charged in an Information with one count of making false statements.

According to the Information, 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.

The Information specifically charges that on September 25, 2002, BUTKOVITZ made false statements 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.

If convicted on these charges, BUTKOVITZ faces up to 5 years’ imprisonment, to be followed by 3 years of supervised release, and a $250,000 fine.

The case was investigated by the Food and Drug Administration. It is being prosecuted by Assistant U.S. Attorney Jeremy Sternberg in Sullivan’s Health Care Fraud Unit.

The details contained in the Information are allegations. The defendant is presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

U.S. Attorney

CONTACT: Samantha Martin, Press Contact of the U.S. Attorney’s Office,+1-617-748-3139