Code of Marketing Practices

Marketing Practices Review Committee

Report on Code Infractions #42 May 1 - July 31, 2001

1. Company and Issue: AstraZeneca Canada Inc. Series of “Regional Discussion Groups on latest findings on ARBs in heart failure presented at the American Heart Association's 2000 Scientific Sessions.”

Discussion: During late November and early December 2000, the company convened a regional discussion group, by invitation, in 14 cities across Canada. The program objectives, as stated by the company, were to “provide the latest outcome data from AHA 2000 on ARBs in heart failure; discuss the implications of the Val-HeFT results for ARBs in heart failure; and explore the potential impact of ongoing heart failure trials, including CHARM (Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity).” Each session involved a maximum of 15 participants who were led through a series of questions by a peer-group moderator.

The moderators had been previously trained in a facilitation skills workshop. The discussions, of one and one-half hours duration, took place in a boardroom style setting “to promote interaction and discussion”, and were followed by a dinner. The letter of invitation to the physicians stated that “…this program is part of AstraZeneca's ongoing commitment to education in heart failure management…” and...“for your involvement in this program AstraZeneca is pleased to offer you an educational bursary of $250.00 in recognition of your active participation in our group discussion.”

In providing additional explanatory information to the MPRC, the company made the following statement in one of its letters: “These consultative meetings allowed us to collect important information from Canadian cardiologists on the role of ARBs in the current and future management of heart failure. This information will be used to help with the future promotions of our heart failure products.” The company further stated: “… we incorrectly used the term educational bursary; we should have used the term ‘consultant fee'.” In another letter, the company stated: “The intent of the meetings was to collect the opinion of our customers on a recent study… in the area of heart failure. “In this sense, the meetings were consultative and market research focused.”

Decision: The sessions constituted “market research” as defined in Section 12.1 of Rx&D's Code of Marketing Practices. Accordingly, they contravened Section 12.2.1. because the letter of invitation to physicians did not make clear the fact that the sessions were in fact market research, and not simply an occasion “to explore the latest findings on ARBs in heart failure that were presented at the AHA 2000 Scientific Sessions.”

2. Companies and Issue: Bristol-Myers Squibb Pharmaceutical Group and Sanofi-Synthelabo Canada Inc. “Market Research/CHE Initiative on the Avapro/Avalide antihypertension regimen” - phase 2.

Discussion: The market research component of the initiative involved the completion of fifty patient profiles, while the continuing health education (CHE) component involved the convening of one small group learning session with 10-12 general practitioners from the physician's referral base using an irbesartan speaker kit plus a case study developed by the physician from one of the patient profiles gathered during the research. Participants were offered “an honorarium equivalent to $5,000 for the completion of the 50 profiles ($100.00 per profile) and the equivalent of $500 for the CHE case study presentation. In lieu of a $5,000 cash honorarium, you will be able to keep the ABPM monitor at the end of the research period. This machine retails for approximately $5,000. As well, you will receive feedback in the coming months as to the approach that your colleagues across the country are taking with respect to the initiation of irbesartan therapy.”

Decision: The ABPM monitor was given for the use of a specific product, not for general use. As such, giving of the equipment constitutes payment for prescribing a specific medication and therefore contravenes Section 11.1. of Rx&D's Marketing Code, which states, in part: “Member companies must not … conduct ‘special promotions' which cannot be justified if subjected to scrutiny by members of the health professions and the public…”

3. Company and Issue: Eli Lilly Canada Inc. Advertising/Promotion System in the November 21, 2000 edition of MD FaxBulletin.

Discussion: The advertising in question was not submitted to the Pharmaceutical Advertising Advisory Board (PAAB) for preclearance and was therefore found to contravene the Code of Advertising Acceptance of the PAAB.

Decision: Contravention of Section 2.2.1 of Rx&D's Code of Marketing Practices which obligates Rx&D companies to adhere to the PAAB's Code.

4. Company and Issue: Janssen-Ortho Inc. Event entitled “All Aboard … bound for Cherry Point Vineyards,” held June 16, 2001, British Columbia.

Discussion: The flyer relating to the event included a “Dear Doctor” letter inviting physicians “to attend a CME picnic at Cherry Point Vineyards in Cobble Hill.. . The CME activity will consist of small workshops conducted by local specialists in Psychiatry, Women's Health, and Infectious Disease… “There will be numerous activities including a Wine Tour, The Art of Wine Tasting, Live Band, Volley Ball, Croquet, Badminton, face painting, and even the world class magician ‘Eric Bedard' will perform close-up magic.” The itinerary for the day, as outlined on the flyer, included departure from Victoria by train at 10:30 a.m., departure at 12:10 p.m. by bus to Cherry Point Vineyards, a Wine Tour and Wine Tasting at 12:45 p.m. followed by lunch, with the CME Round Table Workshops beginning at 2:30 p.m., departure by coach for Cherry Point at 4:30 p.m., and arrival at Victoria at 5:30 p.m.

Decision: Contravention of Section 4.2.3. as the event was designated “CME” but there was no indication that it adhered to the criteria necessary for it to be so designated. In addition, the event contravened Section 4.3.4. in that the many social components of the program far outweighed the educational component, and contrary to the Code, Janssen-Ortho defrayed the cost of transportation and the “numerous activities” that were offered.

5. Company and Issue: Organon Canada Ltd. Stirrup cover bearing the product name, Marvelon.

Discussion: The item in question was a stirrup cover, made of felt, for physicians' examining rooms, and bearing the brand name, Marvelon.

Decision: Contravention of Section 11.2 which defines acceptable service-oriented items as only those whose primary goal is enhancement of the health care practitioner's/patient's understanding of a condition or its treatment.

6. Company and Issue: Pfizer Canada Inc. Event entitled “La maladie cardiovasculaire: regard sur la prise en charge du patient vulnerable” (“Evolving Cardiovascular Continuum: Insights into managing the patient at risk”) held during April and May 2001.

Discussion: The scientific program was accredited, and planned and developed in partnership with a national specialty society and a Canadian university. The faculty was national in scope; and the educational component of the program lasted approximately eleven hours. The program was convened in four venues: two in Toronto; one in Vancouver; and one in Quebec, and the company defrayed the costs of travel and accommodation for all participants at each venue.

Decision: The scientific component of the program was an accredited one and obviously of high quality. The program conformed to five of the six criteria outlined in Section 4.3.5. of the Code of Marketing Practices. However, the program was convened in four different venues, with two of them being in the same city. Accordingly, there was a contravention of Section 4.3.5. which permits payment of travel and accommodation expenses for specialists attending a CHE program only if the program is convened in one location in Canada.

7. Company and Issue: Wyeth-Ayerst Canada Inc. Unapproved advertising for product, Enbrel in Pharmacy FaxBulletin

Discussion: Violation of the Code of Advertising Acceptance of the Pharmaceutical Advertising Advisory Board.

Decision: Contravention of Section 2.2.1. which obligates Rx&D members to adhere to the PAAB's Code.

SUMMARY - REPORT #42