TOPEKA, KAN. – A physician and a clinical research coordinator have been indicted on charges of falsifying study data in a clinical drug trial they were paid to conduct, U.S. Attorney Barry Grissom said today.

Wayne Spencer, 73, Topeka, Kan., a licensed physician, and Lisa Sharp, 48, Olathe, Kan., a clinical research coordinator, are charged with one count of conspiracy, three counts of mail fraud, and one count of falsifying information required by the Food and Drug Administration. The crimes are alleged to have occurred from January 2010 to May 2010 in Johnson County, Kan.

The indictment alleges Sharp and Spencer were employed by Lee Research Institute. Lee Research Institute was hired by Schering/Plough, a pharmaceutical company, to perform clinical drug trials on a tablet developed for treatment of allergies. Spencer was the principal investigator for the clinical study and Sharp was the director of clinical trials for Lee Research Institute.

Schering/Plough’s plans for the study called for all test subjects to be 50 years of age or older and to suffer from ragweed-induced allergy symptoms. Schering/Plough required that employees of the clinical trial facility be excluded as test subjects.

Sharp and Spencer reported that eight test subjects were qualified, even though they knew two of the subjects were not qualified. The two subjects were employees at Lee Research Institute, who were using false names and dates of birth to participate in the study. Both were under 50.

The indictment alleges Sharp and Spencer provided false information on the test subjects. They falsely stated physical examinations had been conducted on the two unqualified subjects. They signed false statements to FDA indicating the clinical study was being conducted in accordance with proper protocol. They also arranged for the unqualified subjects to have office visits while the executive director was at lunch in order to conceal from her the fact the subjects were ineligible. As a result, Schering/Plough issued checks totaling more than $30,000 to Lee Research Institute in payment for the clinical study.

If convicted, they face a maximum penalty of five years in federal prison and a fine up to $250,000 on the conspiracy charge, a maximum penalty of 20 years and a fine up to $250,000 on each of the mail fraud charges and a maximum penalty of three years and a fine up to $10,000 on providing false information to the FDA.

The Food and Drug Administration investigated. Assistant U.S. Attorney Tanya Treadway is prosecuting.

OTHER INDICTMENTS

A grand jury meeting in Topeka, Kan., also returned the following indictments:

Wendy M. Parmenter, 37, Emporia, Kan., a licensed practical nurse, is charged with one count of tampering with a consumer product and one count of adulterating a prescription drug. The crimes are alleged to have occurred in November 2010, in Lyon County, Kan.

The indictment alleges the crimes took place while Parmenter was working as an LPN at Rolling Hills Health Center in Topeka, Kan., which is a nursing home. Parmenter was addicted to Hydrocodone, a painkiller, and frequently ingested morphine prescribed to her patients. When two empty bottles of morphine sulfate were discovered at Rolling Hills Health Center, the nursing director ordered personnel with access to narcotics to have oral swab drug tests. Parmenter failed the drug tests. She passed two subsequent urine drug tests because she convicted another employee to provide urine that she submitted as her own.

A 105-year-old woman who was a patient in the hospital was suffering from dementia and chronic pain. Her physician prescribed morphine sulphate for the pain. Parmenter ingested morphine from the patient’s bottle and added tap water to the bottle to disguise the theft.

If convicted, Parmenter faces a maximum penalty of 10 years and fine up to $250,000 on the charge of tampering with a consumer product and a maximum penalty of three years and a fine up to $250,000 on the charge of adulterating a prescription drug.

The Food and Drug Administration investigated. Assistant U.S. Attorney Tanya Treadway is prosecuting.

Stephen L. Holdren, 60, Overland Park, Kan., is charged with the theft of $31,410, from another person at Ft. Riley. The crime is alleged to have occurred from March 1, 2007, to Aug. 31, 2008, on the base, which is located in Riley County, Kan.

If convicted, he faces a maximum penalty of five years in federal prison and a fine up to $250,000. Army Criminal Investigation Division investigated. Assistant U.S. Attorney Christine Kenney and Special Assistant U.S. Attorney Robin Graham are prosecuting.

Chad Christopher Ramage, 40, Blue Rapids, Kan., is charged with unlawfully possessing a firearm after a felony conviction. The crime is alleged to have occurred Feb. 13, 2011, in Shawnee County, Kan.

If convicted, he faces a maximum penalty of 10 years in federal prison and a fine up to $250,000. The Bureau of Alcohol, Tobacco, Firearms and Explosives investigated. Assistant U.S. Attorney Randy Hendershot is prosecuting.

Sergio Estrada-Ayala, 25, Thornton, Colo., Ciriaco Arellano-Bebollar, 23, Denver, Colo., and Fernando Diaz-Martinez, 29, Denver, Colo., are charged with possession with intent to distribute methamphetamine. The crime is alleged to have occurred May 2, 2011, in Geary County, Kan.

If convicted they face a penalty of not less than 10 years and not more than life and a fine up to $4 million. The Drug Enforcement Administration investigated. Special Assistant U.S. Attorney Duston Slinkard is prosecuting.

In all cases, defendants are presumed innocent until and unless proven guilty. The indictments merely contain allegations of criminal conduct.

 

 

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