Biotech Firm's Director Charged in Software Scheme

A medical director for pharmaceutical and biotech company Serono Laboratories violated federal law by using unapproved computer software to pump up sales of the AIDS wasting drug Serostim, according to charges filed in Boston federal court.

The arrest of Dr. Norma Muurahainen, 56, of Hull, Mass., was the third criminal case filed since 2005 in the alleged Serostim sales scheme. Serono Labs is incorporated in Massachusetts.

The company's parent, Switzerland-based Serono S.A., resolved criminal and civil charges over its Serostim marketing practices in December 2005 by agreeing to pay $704 million in a settlement filed in the U.S. District Court for the District of Massachusetts.

The recent criminal information filed against Muurahainen in the same court says she took part in Serono Labs' effort from 1997 to 2002 to use diagnostic software that essentially "redefined" AIDS wasting to support the marketing of Serostim.

The Food and Drug Administration had not approved the software for calculating involuntary weight loss or "wasting" in AIDS patients.

At the time, Serostim sales were slipping in the face of more effective AIDS drug combinations that also treated wasting.

The criminal information charges Muurahainen with three counts of violating the Food, Drug and Cosmetic Act.

According to prosecutors, the computer software was developed for Serono Labs by RJL Systems Inc. of Clinton Township, Mich.

RJL, Muurahainen and others at Serono knew that the software was not FDA-approved, the information says.

RJL President Rudolph J. Liedtke pleaded guilty in Boston federal court in April 2005 to conspiring with Serono to distribute unapproved software. He is awaiting sentencing.

"Physicians who serve as medical directors of pharmaceutical or biotech corporations are in a unique position of knowledge and responsibility, and must ensure that medical diagnosis and treatment decisions are not based on diagnostic tools whose medical effectiveness and safety have not been established," Boston U.S. Attorney Michael J. Sullivan said in a statement.

"When prescriptions are written based on tests performed with unapproved medical devices, the public is exposed to the risk of receiving potentially unnecessary and harmful drugs," he said.

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