Code of Marketing Practices

Marketing Practices Review Committee

Report on Code Infractions # 46: June 1, 2002 to August 31, 2002

1. Company and Issue: Abbott Laboratories, Limited. Distribution to health care practitioners of black desk clock/file holder bearing the inscription “Fight the Fire,” and the product name “Prevacid.”

Discussion: Documentation submitted by the complainant indicated that the desk clock/file folder was distributed to health care practitioners as part of a campaign to promote the product “Prevacid.”

Decision: The item was found to contravene Sections 11.1 and 11.2 of the Code. Section 11.2 defines “Acceptable service-oriented items” as “Items whose primary goal is to enhance the health care practitioner's/ patient's understanding of a condition or its treatment.”

2. Company and Issue: Abbott Laboratories, Limited. Distribution to health care practitioners of boxes of facial tissues with a “Prevacid Platinum Service” card attached and bearing the name of a representative of the company, a 1-800 number, and the Company's corporate logo.

Decision: The item was ruled to be in contravention of Sections 11.1 and 11.2 of the Code.

3. Company and Issue: Aventis Pharma Inc. Event entitled “Face-off in Cardiology” with subtitle “Hockey Night in Edmonton” held November 20, 2001, at the SkyReach Centre in Edmonton.

Discussion: The evidence provided by the complainant consisted of a two-page invitation, the first of which invited participants to a presentation entitled “Face-off in Cardiology” by a physician, while the second page listed an agenda – as follows – under the heading “Hockey Night in Edmonton: Registration – 5:00 p.m., Keynote speaker – 5:45 p.m., Dinner Buffet – 5:15 p.m., Entertainment – 7:00 p.m. – Edmonton Oilers vs. St. Louis Blues.” It also stated that the dinner buffet/speaker program would be held in the Corporate Boardroom, and that “guests are asked to proceed to the southside Passgate to enter the Skyreach Centre.” The second page of the invitation also provided comprehensive directions as to how guests could reach the Passgate, and included the statement: “Aventis representatives should be around to assist you if necessary.”

Decision: The event was found to be in contravention of Section 4A3.7 which requires, among others, adherence to Section 4A3.4 – social activities must be secondary to the presentation, and must be paid for by the participants.

4. Company and Issue: Aventis Pharma Inc. Event entitled “Managing your High Risk Patients” held March 11, 2002 at the Windspear Centre, Edmonton.

Discussion: Documentation submitted by the complainant consisted of two items. The first was a one-page flyer inviting participants to a presentation on March 11, 2002 on the above-mentioned subject by a physician, and indicating “Registration – 6:00 p.m., Presentation – 6:30 p.m., Dinner to follow.” The flyer included the name of one of the Company's representatives and a telephone number to facilitate responses by the invitees. The second item was also a one-page flyer concerning a concert “Eso-On-the Edge – Blood Red Cherry – a fourth musical harvest from Jann Arden” held on March 11, 2002.

The complainant's allegation was that while the two flyers were not attached to each other, the Company, in fact, paid for the attendance, at the concert, of physicians who participated in the presentation event.

Decision: Following confirmation by Aventis that the Company paid for the physicians' attendance at the concert, the event was ruled to be in contravention of Section 4A3.7 of the Code because of its non-adherence to Section 4A3.4 – social activities must be paid for by the participants.

5. Company and Issue: Bristol-Myers Squibb Canada Inc. Event entitled “Banff HIV Retreat,” held June 14-16, 2002, at the Buffalo Mountain Lodge, Banff.

Discussion: Documentation submitted by the complainant was a one-page flyer extending an invitation “…to attend a weekend full of relaxation and workshops in a majestic setting…Proposed topics include: Case Studies workshop; Managing Sustiva-related CNS Effects; Hepatitis C co-infection; Pipeline drug presentation… Other activities in Banff include: hiking, dining, visiting the hot springs, kayaking, shopping and more…” The flyer also mentioned that flights would depart from Vancouver's International Airport to Calgary on Friday, June 14, 2002 at 3:35 p.m. and would return on Sunday June 16, 2002 at 7:00 p.m. Included in the information provided subsequently by the Company was the following: “The event was attended by 16 physicians, a pharmacist, and two nurses all specializing in the treatment and care of patients with HIV/AIDS…physicians in provinces across the country other than Alberta were offered economy airfare…. no social events were organized or paid for by BMS…even though the program was not accredited… the content was constructed based on verbal feedback from various physicians attending the program… the objective of the program was to provide an overview of various topics and allow for the attendees to participate in interactive sessions.”

Decision: The event was ruled to be in contravention of Section 4A3.5 as two of the six criteria required for an event to qualify for payment of travel and accommodation expenses of participants were not met, namely: “The program is planned, developed and implemented in partnership with a Canadian university or a Canadian national society or association; and “The educational portion meets the requirements of the Maintenance of Certification (MOC) Program of the Royal College of Physicians and Surgeons of Canada.”

6. Company and Issue: Bristol-Myers Squibb Canada Inc. Distribution to health care practitioners of a package of materials consisting of (1) a copy of a reprint from the September 20, 2001 edition of The New England Journal of Medicine (NEJM) discussing the findings of a clinical study on Irbesartan in patients with nephropathy due to type 2 diabetes, (2) a note entitled “Great News with Avapro!” mentioning the study noted above as well as another, and containing the statement “Two studies have shown that Avapro is renal protective… If you have any questions or require samples, please contact me”; (3) a detail piece entitled “Avapro (irbesartan) 150 mg. - All ARBs are not created equal,” and (4) the business card of a representative of BMS.

Discussion: The Committee noted that the item entitled “Great News with Avapro” was stapled to the NEJM reprint, as were the detail piece, and the representative's business card.

Decision: The Committee agreed with the complainant's allegation that the materials were collated and presented in a manner which drew the attention of the reader to the off-label use of the medicine, resulting in claims external to the product monograph. As a result, distribution of the package was found to contravene Sections 8.2.5 and 8.2.6 of the Code. Section 8.2.5 reads, in part: “Representatives must provide full and factual information on products, without misrepresentation or exaggeration…Their assertions must be scientific and should not vary in any way from the official product monograph and current Canadian medical thinking.” Section 8.2.6 prescribes that “Company management shall work with representatives on a regular basis to ensure appropriate information exchange occurs as stated in Section 8.2.5.”

7. Company and Issue: Janssen-Ortho Inc. Event entitled “Second Annual Golf CME – Mood and Your Golf Swing” held May 14, 2002 at the University Golf Course, Univer-sity of British Columbia.

Discussion: As indicated in the event's title, it was designated a “CME” (continuing medical education) event. The invitation listed the name and position of the physician speaker, described “an interactive golf day… 12:30 p.m. tee off… awards and dinner to follow.” It also included the name of a one of the Company's representatives and a telephone number for RSVP purposes.

Decision: Since the event was neither accredited, nor did it meet the principles of adult learning, it was found to contravene Section 4A2.3 of the Code, which prescribes that the designation “CME – continuing medical education” cannot be used unless one of the aforementioned requirements has been met. The event was also found to contravene Section 4A3.4 since the primary focus was on the social, rather than on the information sharing/learning component of the program.

8. Company and Issue: Merck Frosst Canada & Co. An invitation “to celebrate the arrival of spring, Merck Frosst invites (sic) you to a Wine Tasting” held May 16, 2002 at Manoir Montmorency, Beauport, Quebec.

Discussion: The Committee noted that the flyer submitted by the complainant was worded as quoted above, then went on to state the name and position of the speaker and “Topic of the Day HPS Study Results – The most extensive trial ever conducted on a statin.” It also included the names of three of the Company's representatives and the statement “Looking forward to meeting you.” The Company subsequently provided information that included the following: the event began at 6:30 p.m.; 30 minutes were allowed for attendees to arrive and assemble; the presentation of medical information started at 6:30 p.m. and concluded at 7:30 p.m.; the question/discussion period continued until 8:00 p.m. at which time dinner was served and discussion continued; dinner consisted of a three-course meal, with a different wine being served with each course, hence the reason why the words “wine tasting” were used in the invitation. The Company also expressed the opinion that because of “…the conduct of the event, the focus on the presentation of the results of a landmark clinical trial and the improvement of medical care…,” the program did not contravene the Code.

Decision: Notwithstanding the explanatory comments provided by the Company, the Committee ruled the event to be in contravention of Section 4A3.4 of the Code – emphasis on social, rather than educational portion of program – because the focus of the invitation was a “Wine Tasting,” confirmed by the fact that three wines were served, and that discussion of the HPS Study Results was listed as a secondary feature of the evening.

9. Company and Issue: Pharmacia Canada. Event entitled “Dîner-conférence,” held at the Musée de la Civilisation, Hull, Québec, May 10, 2002.

Discussion: The invitation to the event outlined the program as follows “17:30h-18:00h Cocktail de bienvenue; 18:00h-18:45h Allocution…dans l'auditorium; 18:45h-19:00h Discussion, questions et réponses; 19:00h-20:00h Visite guidée de l'exposition ‘Xi'an; 20:00h-22:00h Cocktail Dînatoire dans le salon des visiteurs à la façon du St-Amour”.. The invitation also stated that : “Les conjoints(es) seront invités à visiter l'exposition ‘Talons et Tentations'pendant la conférence.”

Decision: The event was found to contravene Section 4A3.7 because of its non-adherence to 4A.3.4 – emphasis on the social component of the program.

SUMMARY - REPORT #6