Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
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Wall Street Journal - April 20, 2005
William M. Bulkeley, bill.bulkeley@wsj.com
The Justice department said RJL Sciences Inc., Clinton Township, Michigan, and its President, Rudolph J. Liedtke pleaded guilty to conspiracy charges involving the diagnosis of wasting disease in AIDS patients. Mr. Liedtke faces up to five years in prison and a $250,000 fine, and RJL, which is largely owned by Mr. Liedtke, faces a fine of up to $500,000. As is common in prosecutions, the U.S. attorney agreed to recommend a lighter sentence based on the defendants' cooperation in ongoing cases.
The guilty plea follows last week's indictment of four senior executives of drug-maker Serono Inc., Rockland, Mass., a unit of Swiss drug-maker Ares-Serono SA on charges of offering kickbacks to doctors who prescribed an expensive Serono drug that was meant to treat wasting disease. Serono wasn't mentioned in the information that accompanied Mr. Liedtke's plea, and the Justice department declined comment on any connection.
RJL makes "impedance" devices that measure the rate at which low levels of electrical current pass through the body in order to determine body-fat levels. RJL had sold such devices since the 1980's, with Food and Drug Administration approval, but it had never applied to use them to diagnose wasting, a sudden weight-loss that sometimes accompanies AIDS .
According to the agreed statement of facts filed by the parties in the case, RJL wrote new software for its devices that purported to diagnose AIDS wasting, although the devices weren't approved by the FDA for measurement of loss of lean body mass, a key characteristic of wasting. Rather than show an acceptable range of results from tests using the device, "In crafting the "Y software," defendants had eliminated any standard deviation from the software pursuant to express directions from others for the purpose of identifying purported candidates for receiving the drug, and promoting sales of the drug," the guilty plea said.
The statement said "The purpose of the conspiracy was to increase the market for BIA devices and computer software and to increase the market for a drug approved by the FDA to treat AIDS wasting." It said that from 1996 to 2002, RJL and Mr. Liedtke engaged in the conspiracy, including training others to give the tests and obtain reimbursement for the drug.
Mr. Liedtke didn't return calls or e-mails seeking comment.
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