Code of Marketing Practices

Marketing Practices Review Committee

Report on Code Infractions #47 - September 1, 2002 to December 31, 2002

1. Company and Issue: Abbott Laboratories, Limited. Event entitled “L'Obésité: Mise à jour,” held June 13, 2002, Club de Golf de la Vallée du Richelieu, Ste-Julie de Verchères, Québec.

Discussion: The Company convened “a problem-based learning workshop”; during the morning of June 13 followed by a luncheon. In the afternoon, several of the workshop participants accepted the Company's invitation to play golf, at the Company's expense. The Company claimed that “two events were held that day without necessarily the same participants at both,” and that one was an educational event and the other a separate entertainment event.

Decision: The Committee ruled that the program was not two separate events, but one event involving a social activity paid for by the Company. The program was ruled in contravention of Section 4A3.4. of the Code, which requires that, social events, other than meals, must be paid for by the participants.

2. Company and Issue: Abbott Laboratories Limited. Distribution, to health care practitioners, of a measuring tape encased in a plastic container bearing the product name “Meridia.”

Discussion: The item did not meet the Code's definition of "acceptable service-oriented items."

Decision: Contravention of Section 11.2.

3. Company and Issue: Allergan Inc. Study entitled “Lumigan Early Experience Data Trial (L.E.E.D).”

Discussion: According to information provided by the Company, the project was a “clinical evaluation of Lumigan,… an open-label, non-comparative clinical evaluation… akin to a pharmacoeconomic or compliance trial…” whose objective was “to evaluate the ocular safety and efficacy of Lumigan.” The documentation package that was provided to participants contained a “Dear Doctor” letter which read, in part, “…this is an opportunity for you to be one of the first physicians to assess the favourable ocular safety profile and efficacy of Lumigan in your clinical practice…” Participants were provided with materials “for the enrolment of ten patients with open-angle glaucoma or ocular hypertension who are in need of additional IOP-lowering, or are intolerant of other IOP-reducing medications.”

Participants were paid a trial honorarium of $100.00 for each set of forms completed, with up to $1,000.00 for ten sets of patient case report forms.

In responding to the Committee's request for confirmation that the trial was carried out in accordance with Good Clinical Practice guidelines, the Company responded that the trial was designed to collect data from patients that the physician had chosen to place on Lumigan as a result of their personal clinical judgement. In the words of the Company: “The trial was not designed to influence or alter the patient treatment in any way, it was essentially passive surveillance… we consider the trial to be akin to a pharmacoeconomic or compliance trial as stated in the Food and Drug Regulations amendment (Schedule 1024)…”


Decision: MPRC members concluded that the trial was, in fact, a clinical study as evidenced by its designation, objectives, and trial design as outlined in the documentation provided by the Company. Members also agreed that the program involved research on humans and therefore, contrary to the Company's view, the study did require review by a research ethics board. As a result, the study was ruled to be in contravention of Section 9.2.5 of the Code which lists the various legislation, regulations, guidelines, and policy statements to which post registration clinical studies must conform.

Appeal: The Company filed an appeal of the MPRC's decision, and the appeal process was initiated. However, before the hearing could be convened, the Company terminated its membership in Rx&D and subsequently confirmed that it did not wish to pursue the matter.

4. Company and Issue: AstraZeneca Canada Inc. A market research initiative carried out by a representative of the Company among a number of physicians.

Discussion: By means of a letter from the representative, physicians were advised of their selection to participate in a “market research project concerning a new product and new therapies in dyslipidemia.” The project involved a computer laptop program whereby the representative asked several questions “regarding your treatment preferences and disease management of dyslipidemia.” The information gathered by the representative involved a product still in development but identified to the participating physicians by its brand name. Physicians were asked to rank existing, competitive products, and about the likelihood of their prescribing the product still in development.

The Company confirmed that the information gathered on the laptop would be downloaded to a third party. However, the MPRC noted that because of the market research program, the representative would have, on her laptop, data on the prescribing habits and various opinions of the physicians and would therefore be aware of information which should be known only to a third party.

While the Company also confirmed that the data collected would be reported in aggregate form at the provincial level, the MPRC again noted that the representative would be in possession of data on the prescribing patterns of individual physicians.

Decision: The program was ruled to be in contravention of Section 12.2.1. of the Code, in particular, that portion of the section which states that “Market research must not be a disguise for selling or developing sales contacts.” The program was also found to contravene Section 12.2.3 which reads as follows: “Even when a consent form is not signed, the confidentiality of the participant(s) must be preserved. The identity of the participant(s) must not be revealed for the purposes of promoting company products to them….”

5. Company and Issue: AstraZeneca Canada Inc. “Managing a Variable Disease: A National Primary Care Consultancy Program” conducted in nine cities across Canada in 2002.

Discussion: : Information provided by the Company indicated that the program was convened “to obtain feedback and input from primary care physicians with regard to current treatment of asthma and the potential role for the product, Symbicort.” MPRC members also noted that the participants “…were invited as consultants… and that the information and input received from this program will be utilized by AstraZeneca to fine tune and regionalize various marketing initiatives, and that it will be used to further develop our regional/provincial marketing plans.”

In examining the stated objectives and agenda for the “Consultancy Program, ” some members felt that it could be perceived as a continuing health education event for which travel and accommodation expenses were paid to all participants, in contravention of the Marketing Code. All members concluded that the use to which the information would be put placed the activity in the realm of “market research.”


Decision: The activity conformed to the definition of “market research” (Section 12.1) of the Code, and therefore contravened Section 12.2.1 which reads as follows: “The purpose of an individual or group interview must be made clear to the participant(s). Market research must not be a disguise for selling or developing sales contacts. Nor should it deliberately sway the opinion(s) of the participant(s).”

Appeal: The Company filed an appeal of the Committee's decision, and a hearing was convened in accordance with the Enforcement provisions of the Marketing Code. The Arbitrator upheld the MPRC's decision.

6. Company and Issue: Hoffmann-La Roche Limited. Event entitled “Obesity and Diabetes: Which do you treat first - the chicken or the egg?” held September 20, 2002 at the Glen Arbour Golf Course, Halifax, Nova Scotia.

Discussion: The printed invitation for the event outlined the program as follows: 9:00 a.m. – presentation; 10:15 a.m. – nutrition break; 10:30 a.m. – presentation; 11:20 a.m. – lunch; and 12:20 p.m. group activity. The Company confirmed that the presentation constituted a continuing health education event which met the principles of adult learning as required by the Code. The Company advised that the “group activity” was the choice of a round of golf or a spa session, for which the costs were defrayed by the Company.

Decision: The event was ruled to be in contravention of Section 4A3.4. which requires that payment for social activities, other than meals, must be paid for by the participants.

7. Company and Issue:Janssen-Ortho Inc. Program entitled “Switch to and Assessment of Risperdal Treatment” (START).

Discussion: According to the Company, the program involved two stages – “pre-work” and “an advisory board.” Physicians were asked to participate in an advisory board to give feedback on the use of Risperdal in patients who were, in the opinion of the attending psychiatrist, candidates for a switch to Risperdal from another antipsychotic. “The objective… is to obtain advice based on psychiatrists' experiences.” The Company advised that it was particularly interested in having advice “…on the use of Risperdal in patients who were candidates for a change in medication – specifically with regard to management of side effects, dosing, and to understand better what approach to switching appears to be the best tolerated.”

In preparation for the advisory board, participating psychiatrists were asked to carry out "pre-work," that is, to assess patients "by filling out the START forms at baseline and at the end of 12 weeks." Participating psychiatrists were compensated $400 for assessing an estimated ten patients, and if a participant chose not to switch any patients to Risperdal, or chose to switch 100 patients, he/she received the same amount of compensation ($400). After four months, participating psychiatrists were asked to attend the "advisory board" portion of the program at which the information was collated and presented to them. Attendees at the advisory board were asked to make recommendations "that would be used to guide future Janssen-Ortho initiatives." Attendees at the advisory board were each paid $1,100.

In noting the objective and activity applicable to the "pre work" portion of the program, as outlined by the Company, members of the Committee concluded that the "pre-work" constituted market research, as defined in the Marketing Code and that consequently that particular section (12) of the Code applied.

Decision: The Committee found that the program contravened Section 12.2.1 which prescribes, in part, that “The purpose of (an activity) must be made clear to the participant(s),” and that “Market research must not be a disguise for selling or developing sales contacts.” In arriving at that conclusion, members of the Committee expressed the opinion that the Company did not adhere to the spirit of the commitment by Rx&D members to “deal honestly with health care practitioners, public health officials and the public” as outlined in the General Principles of the Code, and that the true objective of the program was to switch patients to Risperdal.

The Committee also found that the level of remuneration ($400) was in contravention of Section 12.2.2 of the Code which deals with appropriate levels of honoraria for market research. This latter decision took into account the Committee's view that the patient assessment would have already been performed by the physician as part of the normal physician/patient consultation, and that the $400 was simply for completion of the START forms.

Further discussion: In examining the role played by sales representatives in the program, Committee members had recourse to the Company's position that the START program was “not a clinical study… there was no formal protocol, guidelines, or description of the program, … that representatives were directed to verbally describe the process including the advisory board pre-work requirements to participating psychiatrists.”

Decision: The Committee concluded that the program was not “administered by qualified personnel” and that Section 9.2.4. of the Code had also been contravened. The section prescribes that “Other company representatives' role in the process must be limited to the distribution and collection of materials pertinent to the study, on behalf of the medical/scientific department.”

Appeal: The Company filed an appeal of the Committee's decision, and a hearing was convened in accordance with the Enforcement provisions of the Code. The Arbitrator upheld the two contraventions of Section 12 (Market Research), and overruled the contravention of Section 9.2.4.

8. Company and Issue: : Pharmacia Canada. Event entitled “Survivor: The Medical Wilderness – A Special Focus on Calcium Channel Blockers and Anti-Inflammatory Medications” held February 19, 2002 at the Windsor Yacht Club, Windsor, Ontario.

Discussion: The invitation to the event outlined the program as follows: Reception: 6:30 p.m.; and Lecture/Dinner: 7:30 p.m. It also provided the name of the physician speaker who “is inviting you to enter into the medical wilderness to outwit, outplay and outlast. In the end, we will see which medication will be the final evidence-based Survivor.” The names and coordinates of two company representatives were also inscribed on the invitation for RSVP purposes.

The program was not accredited, however, the Company stated that the event was set up as a “workshop,” that a “needs assessment was executed as the start of the program” and that “a post-test evaluation was completed at the end of the program.” The Committee requested further information in order to enable members to determine if the program adhered to the five principles of adult learning as prescribed in Section 4A2.3. of the Code. The Company confirmed that documents relating to needs assessment and evaluations no longer exist, and outlined the role played by the speaker in endeavouring to secure objectives for the event.

Decision: As the Company could not provide confirmation that the five principles outlined in Section 4A2.3. of the Code had been met, the event was found to contravene that section.

SUMMARY - REPORT #47