Former Regional Director of Sales for Serono Laboratories, Inc. Charged with Offering Kickbacks to Doctors, Report U.S. Attorney.

BOSTON, Mass., Dec. 15 /PRNewswire/ -- A Hewlit, New York man was charged today in federal court with offering kickbacks to three New York City doctors by offering them an all expenses paid trip to attend a medical conference in Cannes, France in April of 1999, in return for writing prescriptions of Serostim, a brand of recombinant human growth hormone used to treat wasting in AIDS patients, manufactured and sold by Serono Laboratories, Inc., now known as Serono, Inc., a subsidiary of Ares-Serono, S.A.

United States Attorney Michael J. Sullivan; Peter D. Keisler, Assistant Attorney General of the U.S. Department of Justice's Civil Division; Kenneth W. Kaiser, Special Agent in Charge of the Federal Bureau of Investigation in New England; Kim A. Rice, Special Agent in Charge of the Metro-Washington Field Office of the U.S. Food and Drug Administration's Office of Criminal Investigations; Joseph C. Moraski, Special Agent in Charge of the Boston Regional Office of Investigations for the Department of Health and Human Services' Office of Inspector General; James M. Benages, Regional Director of the U.S. Department of Labor's Employee Benefits Security Administration; and Joseph Finn, Special Agent in Charge of the Boston Field office of the U.S. Postal Service's Office of Inspector General, announced today that ADAM STUPAK, age 40, of 1334 Club Drive, Hewlit, New York, was charged in an Information with three counts of Offering to Pay Illegal Remunerations.

"The Information filed today alleges that a Regional Director of Sales for Serono Labs influenced doctors' decisions regarding what drug to prescribe to HIV positive and/or AIDS patients by paying bribes in the form of expensive trips to Cannes, France," stated U.S. Attorney Sullivan. "When a pharmaceutical employee offers a doctor a kickback to prescribe a drug, that individual invades the trust between the doctor and the patient, and deprives the patient of his right to have the doctor act in the patient's best interest in providing quality health care."

The Information alleges that in April, 1999, STUPAK, worked for Serono, an international pharmaceutical and bio-technology company with corporate headquarters in Geneva, Switzerland and US headquarters at the time in Norwell, now in Rockland, Massachusetts. STUPAK was the Regional Director for sales in New York City and was responsible for sales and marketing of the drug Serostim, which is the propriety name or trademark of the generic drug, "somatropin." Somatropin is recombinant human growth hormone that received accelerated approval from the U.S. Food and Drug Administration ("FDA") in 1996 for Serostim to treat AIDS wasting, also known as "cachexia," a condition involving profound involuntary weight loss in AIDS patients. At the time the FDA approved Serostim, AIDS wasting was an AIDS defining condition that constituted the leading cause of death among AIDS patients.

The Information alleges that Serostim came on the market concurrently with the advent of protease inhibitor drugs. These drugs, often referred to as Highly Active Anti-Retroviral Therapy, dramatically curtailed, in the United States, the proliferation of the AIDS virus itself, particularly when used in combination with one another (commonly referred to as "AIDS cocktails"). Given the decreased viral loads in HIV patients taking these drugs, the incidence and prevalence of the AIDS wasting syndrome began to markedly decline among AIDS patients. Consequently, the demand for Serostim began to drop significantly immediately following its launch in the Fall of 1996.

According to the Information, by February, 1999, the Serono business unit responsible for selling Serostim, Metabolic & Immune Therapy ("M & IT"), was falling ...