WICHITA, Kan.—A Topeka doctor who conspired to falsify data in a 2010 clinical trial of an allergy pill on human subjects has asked a judge to spare him from prison.
Food and Drug Administration. Sentencing for Olathe nurse Lisa Sharp is March 23.
Both defendants worked for Lee Research Institute, which was paid by Schering-Plough to conduct the clinical trial on the allergy medication. Spencer was the principal investigator and Sharp was the lead research coordinator.
A presentence report recommends Spencer receive 18 to 24 months in prison, but his attorney this week filed an unopposed request for probation. The government in its plea deal has agreed to recommend probation.
Defense attorney Jason Hoffman argued in a court filing that his client did not personally gain anything from the $36,046 paid to Lee Research Institute for the clinical trial. He contended that the loss figure, which is used to calculate sentencing guidelines, disproportionately punishes the doctor.
His attorney also argued that Spencer was not the "lead actor" in the case, blaming Sharp for enrolling the inappropriate clinical trial participants. He contends it wasn't until the study was under way that it came to Spencer's attention that "something was afoot."
"He was presented with the proverbial Catch-22: allow the study to continue in violation of the study protocol or blow the whistle," Hoffman wrote. "The second option was, of course, the 'correct' one, but the likely fallout would have been to put all the nonphysician employees of Lee Research Institute out in the street."
That is how Sharp presented it to his client, he said.
"In the end, Dr. Spencer chose what he viewed to be the lesser of two evils," according to the filing. "The difficult position Ms. Sharp put him in in no way lessens Dr. Spencer's culpability in this case. It does, however, provide a framework from which to analyze how someone of Dr. Spencer's character and background could find himself staring down the barrel of a prison sentence at this stage in his life."
His attorney also argued that Spencer has been an otherwise law-abiding citizen.
Spencer voluntarily surrendered his medical license in December.
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