Code of Marketing Practices

Marketing Practices Review Committee

Report on Code Infractions # 49: April 1, 2003 to June 30, 2003

1.  Company and Issue:  Bayer Inc. Program entitled, “Find Out About Avelox's Symptom Resolution Time (FAST).”

Discussion: According to the program's “Overview/Protocol” distributed by the Company, the “study purpose (was) to evaluate Avelox's speed of symptom resolution and understanding of Avelox patient profile,” and its “Outcomes” (were) “time to symptom resolution, time to return to usual daily activities, and compliance. The “Overview/Protocol” provided for the following steps: “Physician: Step 1 – Complete Personalized Consent Form – complete and fax personalized consent form for reimbursement; Physician: Step 2 – Identify Patients – identify 10 RTI patients where Avelox is an appropriate choice (acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia, and acute bacterial Sinusitis); Physician: Step 3 – First Patient Visit – 1. for each patient enrolled, complete the profile portion of the Patient Profile/Survey Form and prescribe an appropriate antibiotic, 2. Inform patients that the receptionist will call patients in 7 days to survey antibiotic effectiveness; Receptionist/Physician: Step 4 – After patient's first visit – 1. complete the Patient Tracking Form, and briefly review the survey questions with the patient, 2. contact the patient 7 days after treatment initiation and complete the survey portion of the Patient Profile/Survey Form, Step 5 – Fax back the completed form to Bayer.

In providing additional information on the program for the benefit of the Committee, the Company stated that Bayer's Medical Department “developed the program content and questionnaires”; the objective of the program was to “obtain physician and patient feedback on Avelox, specifically, patient symptom improvement, patient profile (age, indication, and risk factors) and compliance.”

In reviewing the objective of the program, the Committee agreed that the FAST Survey met the definition of Post Registration Clinical Studies as defined in Section 9.1 of Rx&D's Code, and that it fell within the framework of Section 9.2.1 which outlines the general principle underpinning such studies.

Decision:  The Committee ruled that the program contravened Section 9.2.5 of the Code because it did not comply with the requirements for the conduct of Post Registration Clinical Studies as outlined in that sub-section.

2.  Company and Issue:  Eli Lilly Canada Inc. Two events entitled “Olanzapine as a Mood Stabilizer for Bipolar Disorder” convened on September 24, 2002; the first, at 12 noon at the Providence Continuing Care Centre, Kingston, ON, and the second at 7:00 p.m. at The Sutton Place Hotel, Toronto, ON.

Discussion:  The Company stated that the “programs were designed to provide a forum for the exchange of information on clinical and scientific issues,” that they “were directed to healthcare practitioners in the field of psychiatry… that “the audience at both these presentations consisted of psychiatrists, nurses, and pharmacists… that “any reference to the use of Olanzapine in bipolar studies was prefaced with a statement indicating that Olanzapine is not authorized for use bipolar disorder in Canada… and that “Lilly's role in sponsoring these presentations was disclosed to the participants.” Both programs featured one speaker, the Medical Director of the Zyprexa (Olanzapine) Product Team, Lilly Research Laboratories, whose presentation was entitled “Clinical Review of Zyprexa (Olanzapine) in the Treatment of Bipolar Disorder.”

After examining the text of the Medical Director's presentation, members of the MPRC were unanimous in the view that its focus was clearly the medication, Zyprexa, that it
was not balanced but was, in fact, promotion of an off-label use of a medicine by a representative of Eli Lilly to a Canadian audience. Members also agreed that the two events were promotional in nature and against the spirit of the second bullet of Section 4A1.2 of the Code, which reads, in part, “provide a balanced program of current scientific, biomedical or other relevant information…”

Decision: Each event was ruled to be in contravention of Section 8.2.5 of the Code which stipulates that information “.. should not vary in any way from the official product monograph and current Canadian medical thinking.”

3. Company and Issue:  SOLVAY PHARMA Inc. Distribution of post-it notes bearing the product name, Teveten.

Discussion: The front side of the item bore the inscription “Teveten – eprosartan mesylate – antihypertensive,” the company's name, and an anatomical illustration, while the other side repeated the name of the product, included the tagline, “Effective hypertension control – low potential for drug interactions,” and information regarding indications and contraindications regarding the medicine.

Decision: The post-it note was found to contravene Sections 11.1 and 11.2 of the Code – distribution of an unacceptable service-oriented item

4. Company and Issue:  SOLVAY PHARMA Inc. Workshop entitled, “Cardi-Active Drug Interactions CME Program,” held October 24, 2002, Blackfoot Inn, Calgary, AB.

Discussion:  The program for the event provided for a breakfast at 7:00 a.m. with the workshop beginning at 7:30 a.m. Learning objectives were listed as the following: “Understand importance of drug interactions in clinical practice; review types and clinical consequences of drug interactions related to cytochrome P-450 enzyme metabolism; identify patients susceptible to drug interactions; identify drugs (including herbal and OTC remedies) likely to create adverse drug interactions; (and) learn to avoid and deal with drug interactions.” Three case studies were also outlined. The program also listed the names of the “Contributing Editorial Faculty” and the “External Reviewers.” Inscribed on the invitation was the following notation: “This program has been submitted for 2 hours MAINPRO-C Credits.” Subsequent information provided to the MPRC indicated that the event was accredited by the College of Family Physicians (CFPC) and that the accreditation had been extended retroactively to April 18, 2002.

In looking at the relevant dates, MPRC members took cognizance of the time lapse between the CFPC's letter of June 14, 2002 to the president of a medical communications company confirming the accreditation, and the date of the event – October 24, 2002. They concluded that SOLVAY PHARMA had sufficient time to ensure that the correct accreditation information was printed on the flyer relating to the event, or to correct whatever administrative errors might have been made in the preparation of the flyer.

Decision: The event was found to contravene Section 4A.1.2 which obligates Rx&D members to “support, where possible, the principles and practices of CHE programs established by practitioner bodies such as… the College of Family Physicians of Canada.”

Other: The Company subsequently provided information indicating that the event had not taken place, but had been cancelled “at the last moment” due to the unavailability of the speaker. As a consequence, the Company sought to have the contravention of the Code nullified. In discussing the Company's request, members of the MPRC were unanimous in concluding that the fact the event did not take place was irrelevant to the issue, namely inclusion on the invitation of the following statement which is expressly forbidden by the CFPC: “This program has been submitted for 2 hours MAINPRO – C credits.” Members of the MPRC agreed that the wording on the invitation constituted evidence of intent to convene the session, and that while the event did not take place, that development did not eliminate the fact that the Company acted inappropriately in the matter. The original ruling of the Committee was affirmed.

5. Company and Issue:  Wyeth-Ayerst Canada Inc. Event entitled, “Case Study Review: Anxiety/Depression”, held November 21, 2001 at the Cooking Studio, Windsor, ON.

Discussion:  The invitation to the event read as follows: “The Cooking Studio – you are invited… to a case study review: anxiety/depression at the Cooking Studio, hosted by Wyeth-Ayerst.” It also provided the name of the presenter, mentioned a reception to begin at 6:00 p.m., and an ”interactive cooking class” at 6:15 p.m., to be “followed by case study and dinner.”

In elaborating on the event for the benefit of the Committee, the Company discussed the nature of the case study that lasted approximately one hour, provided a copy of the case study, and confirmed that the demonstration and interactive cooking class began at 6:15 p.m. and “was followed by 15 – 20 minutes of food preparation by the physicians.” In addition, the Company reported that “the cooking class was included as part of the meal cost and there was no additional surcharge for the cooking class.”

Decision: Members concluded that the emphasis of the program, as well as the time devoted to the various activities, were on the social, rather than the educational, aspects of the event. As a result, they ruled the event to be in contravention of Section 4.3.4, which prohibits payment by Rx&D members for social/recreational activities.

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

SUMMARY - REPORT #49