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WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Ethical Principles for Medical Research Involving Human Subjects
Robert R. Courtney, 49, of Kansas City, Missouri, and his corporation, Courtney Pharmacy Inc., pleaded guilty on February 26 to 20 felony criminal charges related to the incorrect preparation and dispensing of cancer drugs.
Courtney and his corporation have admitted to the following crimes:
On eight occasions between May 17 and June 19, 2001, he committed "consumer product tampering" by preparing i.v. solutions that did not contain the amount of paclitaxel or gemcitabine ordered by the treating physician. This tampering resulted in serious bodily injury and involved a substantial risk of death to the affected patients.
On six occasions—three times each on August 7 and 13, 2001—he committed "adulteration of a drug" by preparing i.v. solutions that did not contain the amount of paclitaxel or gemcitabine ordered by the treating physician. He did this knowing that the drug solutions’ strength and potency were less than that represented on the labels.
On six occasions—three times each on August 7 and 13, 2001—he committed "misbranding of a drug" by labeling containers of paclitaxel or gemcitabine to misrepresent the actual strength and potency of the drug in the corresponding i.v. solution.
Through his plea agreement, Courtney has admitted that he also diluted and tampered with paclitaxel and gemcitabine solutions administered to 26 additional patients, for a total of 34 persons. He also admitted that he diluted and tampered with cisplatin and carboplatin on an unspecified number of occasions. In addition, he admitted that he conspired to traffic in stolen drugs and that, by tampering and diluting drugs but not informing the treating physician, he caused that physician to file false Medicare claims.
An ongoing investigation into the Courtney case has resulted in at least four other people confessing to dealing in stolen prescription drug products.
Two of those cases involved retired pharmaceutical salesmen who admitted to buying stolen drugs from a man who worked in the pharmacy storeroom of the University of Colorado Hospital in Denver. The former hospital worker confessed in April to stealing drugs from the facility and selling them.
The investigation also netted a Kansas City pharmacist who, through a plea agreement, surrendered his pharmacy license to state authorities in Kansas and Missouri.
Gary S. Ravis, 58, pleaded guilty to knowingly buying stolen drugs from one of the salesmen. Ravis was sentenced in April to five years of probation, 2500 hours of community service, and a $250,000 fine. He must spend the first six months of his probation under electronic monitoring in his home.
Source: Office of the United States Attorney for the Western District of Missouri.