Eli Lilly and Company Shares Timeline of Its Activities in Alleged Drug Dilution by Kansas City Pharmacist; Sales Representative Raised Concerns of Drug Dilution on May 15, 2001.Business Editors, Health & Medical Writers INDIANAPOLIS--(BW HealthWire)--Aug. 31, 2001 Due to widespread mischaracterizations of the company's actions in the alleged drug dilution case involving Robert Courtney's Research Tower Pharmacy, Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. today made available a summary timeline of the company's activities in this matter. Courtney is being held without bail in Kansas City Kansas City, two adjacent cities of the same name, one (1990 pop. 149,767), seat of Wyandotte co., NE Kansas (inc. 1859), the other (1990 pop. 435,146), Clay, Jackson, and Platte counties, NW Mo. (inc. 1850). on criminal charges of violating federal drug laws. As the Lilly sales representative, Darryl Ashley, has related to both Lilly and the Grand Jury investigating Courtney, Ashley first suspected that Courtney was diluting Gemzar(R) and other products on May 15, 2001. On May 15, 2001 Ashley visited the office of Dr. Verda Hunter, a doctor who purchased cancer drugs from Courtney's pharmacy. During that visit, Ashley discussed with Hunter's nurses difficulties he was having in reconciling Gemzar sales data derived from multiple sources. In that same meeting, after Ashley raised concerns about the sales data, two office nurses raised their observations that: -- patients were not having the common side effects associated with the particular chemotherapy administered. For example, patients taking Taxol(R), a Bristol-Myers Squibb Co. chemotherapy drug, were not losing their hair, and patients taking Lilly's Gemzar were not experiencing nausea. -- the IV bags containing Gemzar and Taxol did not always appear full when they came from Courtney's pharmacy. The May 15 meeting ended with both sides concerned about possible dilution by the pharmacy. This meeting set forth a chain of events that led to the 20 indictments against Courtney. "Our sales representative brought forward an important piece of the puzzle to the physician, who had access to all the information necessary to bring this case forward to authorities. We are pleased that our sales representative played an important role in helping uncover this unconscionable Unusually harsh and shocking to the conscience; that which is so grossly unfair that a court will proscribe it. When a court uses the word unconscionable to describe conduct, it means that the conduct does not conform to the dictates of conscience. activity," said Steve Plump, vice president, sales and marketing for Lilly's U.S. affiliate. Ashley's account demonstrates that the observations he and his managers made before May 15, 2001 have been seriously mischaracterized. "Mr. Ashley had no reason to suspect any dilution before May 15," said Plump. "The charge that Lilly would somehow 'cover up' knowledge that our product was being diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. defies logic. Neither Lilly, patients nor the physician would benefit from the continued misuse of a life-saving oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. drug. Instead, if the facts reported in the media are true, it would appear that pharmacist pharmacist /phar·ma·cist/ (fahr´mah-sist) one who is licensed to prepare and sell or dispense drugs and compounds, and to make up prescriptions. phar·ma·cist n. Robert Courtney Robert Ray Courtney (born 1952 in Hays, Kansas) was a pharmacist who owned and operated Research Medical Tower Pharmacy in Kansas City, Missouri. Over a period of about 9 years he diluted an estimated 98,000 prescriptions of medications, affecting some 4,200 patients; many had a strong motivation to dilute di·lute v. To reduce a solution or mixture in concentration, quality, strength, or purity, as by adding water. adj. Thinned or weakened by diluting. products from several manufacturers - essentially to increase profits for his business." Attached is the summary timeline: 2000- Lilly sales representative, Darryl Ashley visits Dr. Verda Hunter's office based on her specific request. As part of routine sales tracking, Ashley asks Hunter's office to provide documentation of quantity of Gemzar used in her practice; Hunter requests reports from Robert Courtney's pharmacy ("Courtney Reports") that describe the Gemzar ordered by Hunter from Courtney. Hunter's office provides these quarterly reports to Ashley in August, November, and year-end 2000. Total quantities of Gemzar reflected in the Courtney Reports are used to determine Ashley's bonus compensation in lieu of Instead of; in place of; in substitution of. It does not mean in addition to. using wholesaler-supplied data obtained from the reporting service, IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. ("Wholesaler Reports"). The Wholesaler Report for accounts in this area are deemed unreliable due to a history of wholesalers that supply this area failing to report sales data to the reporting service, IMS. January, 2001- Lilly sales management Sales Management Role and Goal Importance of sales management is critical for any commercial organization. Expanding business in not possible without increasing sales volumes, and effective sales management goal is to organize sales team work in such a manner that ensures a determines that the wholesaler for the area is now reporting and that the Wholesaler Reports are accurate enough to use going forward as a basis for calculating representative bonuses. April 10, 2001-In response to request from Ashley, nurse in Hunter's office provides Ashley Courtney Report for the 1st quarter of 2001; Ashley has access to Wholesaler Report, available to Lilly via IMS reporting service, that Lilly now believes is accurately showing the amount of drug shipped to Courtney's pharmacy by reporting wholesalers; Ashley begins to compare the amount of Gemzar dispensed dis·pense v. dis·pensed, dis·pens·ing, dis·pens·es v.tr. 1. To deal out in parts or portions; distribute. See Synonyms at distribute. 2. To prepare and give out (medicines). 3. from Courtney's pharmacy (according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the Courtney Report) to the amount of Gemzar shipped by the wholesaler to Courtney (according to Wholesaler Report). April 24, 2001-May 14, 2001- Ashley off work to care for critically ill child; Ashley continues to review non-Lilly generated Courtney and Wholesaler Reports and develops questions regarding the accuracy of the Courtney Report including discrepancies between the two reports. May 15, 2001- On his first day back to work, Ashley visits Hunter's office and spends two hours working with nurses to analyze the Courtney Report. Ashley raises concerns about the sales data and nurses become increasingly suspicious as they have not been seeing the side effects Side effects Effects of a proposed project on other parts of the firm. that are commonly reported with administration of Taxol(R) (eg., hair loss) and Gemzar(R) (eg., nausea nausea, sensation of discomfort, or queasiness, in the stomach. It may be caused by irritation of the stomach by food or drugs, unpleasant odors, overeating, fright, or psychological stress. It is usually relieved by vomiting. ). This is the first time that Ashley and, apparently Hunter's office, suspect a dilution issue. The nurses also remark to Ashley that the IV bags containing the solution of saline/drug as mixed by Courtney sometimes were not full when they arrived from Courtney's pharmacy. The meeting ends with both sides being concerned about possible dilution by the pharmacy. May 16, 2001- Hunter calls Ashley at home to discuss discrepancies in Courtney Report and the lack of side effects observed with patients receiving Taxol and Gemzar provided by Courtney. May 17, 2001- Hunter sends sample of Taxol supplied by Courtney for testing to the National Medical Services. May 23, 2001- Nurse from Hunter's office asks Ashley whether Lilly could test or recommend a lab that can test Gemzar. Ashley calls his manager who then recommends a company. May 24, 2001- Ashley gets back to Hunter's office with name of the lab, which has previously conducted tests on Gemzar. Ashley also provides Hunter, at her request, with the address of Eli Lilly and Company and the fax numbers of two members of sales management. Ashley offers to provide Hunter with any further assistance she may need on this matter. May 27, 2001- According to the FBI affidavit affidavit Written statement made voluntarily, confirmed by the oath or affirmation of the party making it, and signed before an officer empowered to administer such oaths. supporting the criminal complaint, Hunter telefaxes and mails a letter to Lilly's offices in Indianapolis, noting concerns for patients and requesting help in testing product. Lilly has no record of receipt of this letter. June 2001 (exact date unclear)- Nurse in Hunter's office informs Ashley that lab suggested by Lilly could not do the testing for Gemzar, but does not explain why and does not request additional referral. June 20, 2001- Ashley visits Hunter's office where there is no discussion regarding May 27 letter nor of possible Gemzar dilution. Ashley learns for first time that the Taxol tested was diluted. Nurse informs Ashley that Hunter's office has stopped ordering Stopped Order A market order on the NYSE that is stopped from being executed by the specialist because of a request from a member firm to obtain a better price than that available. any products from Courtney's pharmacy. Ashley believes the doctor's office is continuing its investigation. June 27, 2001- Ashley visits Hunter's office, where there is no discussion regarding the May 27 letter, Taxol dilution, or possible Gemzar dilution. Ashley is told by nurse that Robert Courtney was in the office to ask why Hunter's office was no longer ordering from him. July 11, 2001- Ashley visits Hunter's office for lunch meeting, attended by Hunter, during which there is no discussion regarding the May 27 letter, Taxol dilution or possible Gemzar dilution. July 19, 2001- Ashley's sales partner and sales manager sales manager n → gerente m/f de ventas sales manager n → directeur commercial sales manager sale n → visit Hunter's office to request sales data for the 2nd quarter of 2001. The Lilly sales people meet with a nurse and ask about what side effects the patients receiving Gemzar are experiencing. The nurse was evasive e·va·sive adj. 1. Inclined or intended to evade: took evasive action. 2. Intentionally vague or ambiguous; equivocal: an evasive statement. leading the Lilly representatives to conclude that the investigation was still underway. August 13, 2001- Ashley is contacted by FBI; Lilly learns for the first time from FBI that tests of Gemzar supplied by Courtney show that product was diluted; Ashley and Lilly respond immediately to FBI requests for information in Courtney investigation. A graphic illustration of how Gemzar moves through the distribution chain to patients is available upon request by calling Judy Kay Moore at 317-277-6265 or Jeff Newton at 317-276-3570. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. Gemzar(R) (gemcitabine hydrochloride gemcitabine hydrochloride Warning - Hazardous drug! Gemzar Pharmacologic class: Antimetabolite (pyrimidine analog) Therapeutic class: Antineoplastic , Lilly) Taxol(R) is a registered trademark of Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were Co. |
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