Code of Marketing Practices

Marketing Practices Review Committee

Report on Code Infractions #44 - November 1, 2001 to February 28, 2002

1. Company and Issue: Aventis Pharma Inc. “Osteoporosis Program,” held November 3, 2001 at the Delta Edmonton Centre Suite Hotel, Edmonton

Discussion: The flyer relating to the event provided for registration at 10:30 a.m., to be followed by the presentation at 11:00 a.m. It also included the following statement: “Spa Treatments at Eveline Charles to precede or follow the presentation (based on your preference) at their Edmonton Centre location.” The flyer also contained the name and telephone number of a company representative. The Company advised that the primary purpose of the event was to provide an update on osteoporosis treatments by a clinical specialist. The Company also confirmed that it paid for spa treatments for 17 physicians.

Decision: The Committee ruled that the event contravened Section 4.3.7 which requires, among others, adherence to Section 4.3.4 - social activities must be paid for by the participants.

2. Company and Issue: Boehringer Ingelheim (Canada) Ltd. Event entitled “First Annual Canadian Rheumatology Forum,” held January 31, 2002 - February 3, 2002, Montego Bay, Jamaica.

Discussion: The evidence submitted by the complainant was a letter, on the Company's letterhead, signed by a senior product manager, in which an invitation was extended to “a four day forum…” the intent of which “is to discuss current and future practices in treating arthritis and other pain-related problems with emphasis on some of the controversies that have arisen within the treatment of arthritis.” It also invited prospective attendees “to participate in discussions around COX -2 selective NSAIDS, clinical research and future products for the treatment of arthritis.” The letter outlined a “draft itinerary” and stated that Boehringer Ingelheim would provide “Return airfare - one business class ticket or two economy; three nights accommodation for the duration of the meeting, and transportation to and from the airport.” It asked invitees to complete a form and return it to a third-party organizer, and to contact the company's National Conference Coordinator for responses to any questions.

In responding to the MPRC's request for additional information, the Company advised that the agenda for the Forum was set up by Boehringer Ingelheim International which also paid for “the symposium portion of the meeting as there were participating specialists from eight countries…” The Company also advised that “the faculty was a panel of international and national experts on arthritis” and that there were “…talks, discussions and feedback…” for a total of 10 hours on two days, and that two days were devoted to travel. It also confirmed that it provided a travel and hotel accommodation grant.

Decision: The Committee ruled that the event contravened Section 4.3.7 of the Code which requires, among others, adherence to Section 4.3.5 - travel and accommodation expenses can only be paid to speakers and moderators, not to attendees and/or spouses.

3. Companies and Issue: Bristol-Myers Squibb Pharmaceutical Group and Novartis Pharmaceuticals. Event entitled “The Evolution of IBS Management: Efficacy meets Safety,” held June 8 - 10, 2001, Fairmont Chateau Whistler, Whistler, British Columbia.

Discussion: The evidence submitted by the complainant was a letter personally addressed to individual physicians, and signed by a representative of each of the companies, extending an invitation to the event “on behalf of Novartis Pharmaceuticals Canada Inc. and Bristol-Myers Squibb Pharmaceutical Group.” It stated that the meeting “will bring together some of the key opinion leaders to speak about and discuss the current thinking, research and new treatment options in IBS. “The audience for this meeting will be 750 - 1000 gastroenterologists from all around the world and specialists in the field of IBS. “During the meeting we will focus specifically on one of the newest compounds, Tegaserod. This 5-HT4 receptor partial agonist will be discussed in depth, with the chance for delegates to gain knowledge of its potential therapeutic use.”

A “provisional program” was attached to the letter which also stated that the following expenses will be covered by the sponsoring companies: registration fee for the meeting, hotel accommodation at the Fairmont Chateau Whistler for up to three nights, one return airfare to Vancouver (for flights less than 4 hours - economy airfare, and for flights over 4 hours a business class ticket), ground transfer costs to and from the airports, as well as reasonable out of pocket expenses. The letter also provided details of the social program and advised that additional program information could be obtained from one of two Novartis' personnel whose names and coordinates were listed, and that information on logistical arrangements could be obtained from a representative of a third party Canadian organizer whose name and coordinates were also provided.

Following initial examination of the complaint, the Committee requested further details and were advised as follows: the scientific content and agenda were planned by an international committee under the direction of two co-chairs; the faculty was composed of 23 international experts in the field of gastroenterology and digestive disorders; the meeting was independently planned by the global business units of Novartis Pharma AG, Basle, Switzerland, and Bristol-Myers Squibb Company, Princeton, U.S.A.; Canada was chosen by the international planning committee as the preferred location for the meeting; the more than 600 meeting participants represented some 30 countries around the world; overall meeting logistics were arranged by a communications firm based in the United Kingdom while logistics for the Canadian physicians were handled by a third party organizer, based in Montreal.

The companies also advised that Tegaserod has not received a Notice of Compliance in Canada, and that participants were able to attend “plenary and breakout sessions that focused on a wide range of issues related to the management of IBS.”

Decision: The Committee had no issue with the high caliber and expertise of the international organizing committee and faculty for the event. Members expressed concern about the appropriateness of inviting Canadian health care professionals to a session in which there was a discussion on a product that has not yet been approved for use in Canada. While the event was not organized by the Canadian companies, the invitation did originate with the Canadian companies and was signed by a representative of each of them. As a result, the Committee found that the event contravened Section 4.3.7 of the Code which requires adherence to, among others, Section 4.3.5 prohibiting the payment of travel and honoraria for health care practitioners attending CHE events.

4. Company and Issue: GlaxoSmithKline Inc. Event entitled “Fall Away with GSK: A Focus on Diabetes, Generalized Anxiety Disorder, Migraine, Asthma, Medicine and the Law,” held October 19 - 21, 2001 at Giseles Inn, Baddeck, Nova Scotia.

Discussion: The evidence in support of the complaint included a copy of the program that outlined the topic for discussion on each day, the names of the speakers, as well as a brief outline of the thrust of their presentation. Also included was a copy of a registration form to be completed and returned by prospective attendees. The following information was inscribed on the program: “An application has been submitted to the College of Family Physicians of Canada for consideration of program accreditation for 6.0 Mainpro - M1 credits.” The evidence provided by the complainant also included an extract from a publication of the College of Family Physicians of Canada entitled MAINPRO - A Guide for CME Providers, 2001.

On page 15 of the afore-mentioned publication, under the heading Notice of Accreditation, the following is stated: “No reference may be made to the CFPC or its accreditation system prior to the actual notification that credit has been awarded. “Do not state ‘CFPC credit applied for' or similar wording.”

Decision: The event was ruled to be in contravention of Section 4.1.2 of the Code which obligates the Rx&D membership “… to support, where possible, the principles and practices” of organizations such as the CFPC.

5. Company and Issue: Leo Pharma Inc. Event entitled “ Skin Dermatoses from A to P: Atopic Dermatitis and Psoriasis,” held November 17, 2001 at the Playdium, West Edmonton Mall, Edmonton.

Discussion: The evidence provided in support of the complaint was a copy of an invitation from the Company to “… You (and your Family) For a Lecture…” on the above-mentioned topic.

It provided the names of the speakers for each subject, and outlined an itinerary for the day for the participating physicians as well as for their families. It also contained the statement: “One hour play cards will be given to each family member.”

A registration form, containing the name and coordinates of a Leo Pharma representative was included on the invitation. At the bottom of the form was a statement suggesting casual wear for the occasion, and also suggesting that participants might want “… to plan some early Christmas shopping…”

In responding to the Committee's request for clarifying information, the Company confirmed that it paid for lunch for spouses/companions and children at the event, as well as for the play cards given to children.

Decision: The event was ruled to be in contravention of Section 4.3.4 which prescribes that the costs for social events must be paid for by the participants.

6. Company and Issue: Merck Frosst Canada & Co. Event entitled “Cardiology Update”, held August 30, 2001 at the Fort William Country Club, Fort William, Ontario.

Discussion: The flyer pertaining to the event outlined the program as follows: 6:30 p.m - refreshments, 7:00 p.m. - Presentation, followed by dinner at 7:45 p.m. It also contained the following statement: “This educational program is supported in part by a grant from Merck Frosst Canada Inc.” Although designated an “educational” program the event was not accredited, nor did it adhere to the principles of adult learning as prescribed in Section 4.2.3 of the Code. As a result, it should not have been designated “educational.”

Decision: Contravention of Section 4.2.3.

7. Company and Issue: Novartis Pharmaceuticals Canada Inc. Event entitled “Arts and Science,” held February 17, 2001 at the Provincial Museum of Alberta, Edmonton.

Discussion: The event featured one speaker who addressed the subject of “To ARB or not,” and another whose presentation was entitled “Factors to Consider when Initiating Treatment for Osteoporosis.” The Company received accreditation for the latter-mentioned presentation, but did not apply for accreditation for the first.

Use of the venue by Novartis Canada was free to the Company as a result of the fact that Novartis Basle was a primary sponsor in bringing to Canada a Syrian Exhibit which was featured at the Provincial Museum of Alberta on the date in question.

The printed flyer for the event, submitted by the complainant as evidence, provided the name and phone number of one of the Company's cardiovascular medical representatives who could be reached for further information and to confirm attendance. The printed flyer also contained a handwritten note, allegedly by a representative of Novartis Canada, to the effect that “This is a family event - dinner will be served - we have the whole museum to ourselves.” Also handwritten on the printed invitation were the brand names of two of Novartis Canada's products in the therapeutic categories being addressed.

Decision: The event was ruled to be in contravention of Section 4.3.4 which requires that the costs for social events must be paid for by the participants.

8.Company and Issue: Novartis Pharmaceuticals Canada Inc. Mailing to physicians' offices of complimentary copies of March 5, 2001 edition of Maclean's and March 15, 2001 edition of L'Actualité, each containing a jacket bearing advertising for the product Diovan.

Discussion: The Company confirmed that the mailing included a covering letter, the above-mentioned items, and prescribing information for the product. It also advised that its use of the two publications in question for advertising purposes was “very similar to familiar publications such as Stitches and Doctor's Review in which (sic) the physician takes the publication home and subsequently views the advertisements. “In addition, these publications are free to physicians and generally have little or no medical education.” Members of the Marketing Practices Review Committee noted that, unlike Stitches and Doctor's Review, Maclean's and L'Actualité are weekly newsmagazines, directed to consumers, and are not available free of charge. Members also questioned the Company's view that physicians would actually take the mailings home in order to view the advertisements.

Decision: The mailings contravened Section 11.1 which stipulates that “Member companies must not distribute service-oriented items or conduct special promotions which cannot be justified if subjected to scrutiny by members of the health professions and the public. Member companies should also use good judgement by choosing modes of advertising that will uphold this general principle.” The items were also ruled in contravention of Section 11.2 which defines “acceptable service-oriented items."

9. Company and Issue: Novartis Pharmaceuticals Canada Inc. Event entitled “Ten Most Frequently Asked Questions of a Cardiologist,” held June 6, 2001 at the Caledon Country Club, Caledon, Ontario.

Discussion: While the program - a presentation by a clinical cardiologist - was not accredited, the Company advised that it had met the principles of adult learning as required in Section 4.2.3 and therefore qualified as “educational.” The printed flyer, submitted as evidence by the complainant, made no mention of a golf game, however, the Company, in responding to an enquiry by the Committee, confirmed that golf was available to the participants and that payment for the activity was made by Novartis.

Decision: The event was ruled to be in contravention of Section 4.3.4 which stipulates that social activities must be paid for by the participants.

10. Company and Issue: Pharmacia Canada. Distribution of Obus Forme back support bearing product name “Celebrex.”

Discussion: Following initial examination of, and a ruling on, the complaint by the Committee, the Company provided extensive documentation on the subject of arthritis management, as well as explanatory comments in order to justify its claim regarding “the viability and appropriateness of the Celebrex Back Support Program as a service-oriented item whose goal is to enhance the health care practitioner's/patient's understanding of arthritis and its treatment” in accordance with Section 11.2 of the Marketing Code.

It also cited the findings of various studies/teaching primers that identified “physical and occupational therapy, as well as assistive devices for ambulation and activities of daily living” as part of the non-pharmacological therapy portion of treatment modalities. The Company also provided copies of various patient leaflets it had prepared on various joints in the human body, each of which contained a diagram of the joint in question as well as instructions for exercises that patients could carry out.

The Committee found that the patient information leaflets were informative and useful, both as educational tools for use by physicians and as instructional information for patients. However, members also concluded that the giving of an Obus Forme to a physician does not benefit that physician's individual patients. It only helps the physician, and only in those cases where he/she has back problems. Members affirmed that the only way in which patients could benefit is if they each received an Obus Forme. They also concluded that the Company could better serve the interests of patients if they provided patient information leaflets on arthritis/back support treatment similar to the leaflets developed on various joints, as mentioned above.

Decision: The Committee found that the Obus Forme did not meet the definition of an “acceptable service-oriented item” and therefore contravened Section 11.2 of the Code.

11. Company and Issue: Pharmacia Canada. Program entitled “The Pharmacia Pizza Guarantee.”

Discussion: The evidence submitted by the complainant was in the form of a flyer headlined as above. It included the following message: “When you need samples, please give one of us a call - don't delay! We guarantee delivery of the samples to your office within 48 hours! Or, we will buy pizza for your entire office!!” The flyer also contained the photographs, names and coordinates of three pharmaceutical representatives, and listed the product samples available from each of them.

Decision: The Committee ruled that the program constituted a “special promotion” and therefore contravened Section 11.1 of the Code which prohibits the conduct of special promotions “which cannot be justified if subjected to scrutiny by members of the health professions and the public.” It also ruled that the program contravened Section 8.2.4 which requires pharmaceutical representatives to “display the highest professional and ethical standards at all times.”

12. Companies and Issue: Pfizer Canada Inc. and Pharmacia Canada. Unapproved advertising for product Celebrex.

Discussion: The matter concerned a “Dear Healthcare Professional” letter, dated August 31, 2001, regarding the cardiovascular safety profile of Celebrex. It was ruled to be advertising by the Commissioner of the Pharmaceutical Advertising Advisory Board (PAAB), but had not been submitted to the PAAB for preclearance.

Decision: Contravention of Section 2.2.1 of Marketing Code which requires adherence to, among others, the PAAB's Code.

13. Company and Issue: Wyeth-Ayerst Canada Inc. Event entitled “Core Impulsivity vs. Compulsivity: Serotonin or Norepinephrine - Optimizing Outcomes in the Treatment of Depression,” held November 9-10, 2001, Queen's Landing Inn & Conference Resort, Niagara-on-the-Lake, Ontario.

Discussion: The flyer relating to the event outlined the agenda as follows: Friday - check in after 4:30 p.m.; 7:30 p.m. - welcome reception and cocktails; 8:00 to 9:30 p.m. - buffet dinner. Saturday - 8:00 a.m. - breakfast; 9:00 a.m. - presentation; 10:30 a.m. - presentation; 12:00 Noon - wrap-up lunch. It also stated “space is limited,” and invited those planning to attend to contact one of the company's representatives whose name and coordinates were published on the flyer.

The Company subsequently confirmed the following: the audience for the program was psychiatrists and that approximately 30 psychiatrists attended; the length of the educational portion of the program was four hours; and that Wyeth-Ayerst paid for the hotel accommodation for the attendees.

Decision: The event was found to contravene Section 4.3.5 of the Code as it did not meet one of the criteria (the educational part of the event lasts at least a full day) that must adhered to in order to permit companies to pay hotel accommodation expenses for specialists' continuing health education (CHE) programs.

SUMMARY - REPORT No. 44