Code of Marketing Practices

Marketing Practices Review Committee

Report on Code Infractions # 48: January 1, 2003 to March 30, 2003

1.  Company and Issue:  Amgen Canada Inc. Distribution of a "Dear Healthcare Professional" promotional letter dated September 6, 2002 concerning the product Aranesp.

Discussion:   The item had been ruled by the Commissioner of the Pharmaceutical Advertising Advisory Board (PAAB) to be in violation of that organization's Code of Advertising Acceptance.

Decision:  Contravention of Section 2.2.1 of the Rx&D Code because of violation of  PAAB's Code.

2.  Company and Issue:  Aventis Pharma Inc. Event entitled "Case Studies in Cardiology," ,held December 13, 2002, Corporate Boardroom, Skyreach Centre, Edmonton.

Discussion:  The printed invitation for the event outlined the program as follows: Registration - 5:00 p.m.; Presentation 5:30 p.m.; Dinner to follow.  It included the names of two of the company's representatives with their telephone coordinates. Attached to the invitation was a flyer, which provided directions to the Corporate Boardroom.  The complainant alleged that the invitation to the event also included the opportunity to attend a hockey game that took place at the same venue on the same evening, beginning at 7:00 p.m. at the company's expense, and pointed out that one of the company representatives named on the invitation was also the individual named on invitations to two previous similar events that were found to contravene the Marketing Code because participants to the educational event were also given the opportunity to attend a hockey game at the company's expense.

Decision:  The event was ruled to be in contravention of Section 4A3.7 because it did not adhere to Section 4A3.4 which requires that payment for social activities, other than meals, must be made by the participants.

3. Company and Issue:  Bristol-Myers Squibb Canada Inc. Distribution of badge holder and laniard, bearing corporate name, to health care practitioners at the annual meeting of a national specialty society.

Discussion:  Item in question did not conform to definition of "acceptable service-oriented item."

Decision:  Contravention of Sections 11.1 and 11.2.

4. Company and Issue:  Bristol-Myers Squibb Canada Inc. Conduct of a study entitled "SECURE - Examining Cefzil Utilization in Urban and Rural Environments."

Discussion:  The Company's letter to physicians participating in the project described it as "a drug utilization review designed to help better understand variations in the prescribing patterns of antibiotics for Respiratory Tract Infections which are understood to exist between urban and rural environments.  The objective of this survey is to analyse the rural-urban differences in physician prescribing patterns of cefprozil for respiratory tract infections and to examine the relationship between city size and practice patterns.  A secondary objective is to determine if these differences can be observed across different Canadian provinces." The letter to participating physicians also advised that "the SECURE project has been reviewed by an independent ethics review board and the data will be collected and analyzed without identifying confidential patient information." 

The documentation provided to the physicians included a "Protocol for Cefprozil (Cefzi)l Physician Survey," which included the statement: "Physicians will receive an honorarium for their participation in the study," a fact sheet on antibiotics entitled "What I need to Know," a form entitled "Drug Utilization Survey" to be completed by the physician, and a "Physician Registration Form." The company confirmed that the project was presented to participating physicians (except for one province) by the company's sales representatives who were also required to complete the Physician Registration Form.  

The form to be completed by the physician included a statement of "Patient Consent" to be signed by each participating patient.  It requested information on, among others,  "Previous history of RTI, Previous Antibiotherapy in the last 3 months for RTI, Current Condition: Diagnosis and Symptoms, and Treatment."  The segment of the form headed "Treatment" contained the following information: "Cefzil 250 mg BID - 7 days - 10 days- 14 days - Other; Cefzil 500 mg BID - 7 days- 10 days - 14 days - Other." As noted by MPRC members, the form did not provide for the ability to prescribe any therapy other than Cefzil.

In responding to the MPRC's request for information on $20.00 honorarium, the Company advised that it "was intended to compensate for the time the physician took to explain the program to the patient, to answer any questions the patient might have, to get the patient to fill in (i.e. sign) the Drug Utilization Form, and to fax it to the third party responsible for gathering the data."

Decision:  The SECURE project was found to contravene Section 9.2.4 of the Code, which limits the role to be played by sales representatives in the conduct of post registration studies "to the distribution and collection of materials pertinent to the study." In advising the Company of its decision on the matter, the MPRC also noted the unanimous opinion of its members that the "Drug Utilization Survey" form did not provide participating physicians with the ability to prescribe any therapy other than Cefzil, and suggested that the Company correct that situation in any similar program that it may implement.

5. Company and Issue:  Bristol-Myers Squibb Canada Inc. and Sanofi Synthelabo Canada Inc.  Distribution to health care practitioners of notepads bearing product names "Avapro" and "Avalide."

Discussion:  The item in question measured 5 x 7, and bore, on the front and at the top of the page, the afore-mentioned product names as well as the following: (irbesartan) 50 mg 300 mg" and "Avalide (irbesartan/hydrochlorothiazide 12.5 mg)," and the tagline "Angiotensin II receptor blocker -Treat hypertension to goal."  On the reverse side it repeated the product names and information (except the tagline),  and provided statistical information under the following headings: "Target BP recommendations for the management of patients with essential hypertension (mm Hg); and "Target BP recommendations for the management of patients with hypertension and diabetes ( mm Hg) adapted from respective consensus guidelines."  It also provided information on indications and contraindications on the two products, including a caution as to instances in which the medicines should not be used. 

In adjudicating the complaint about the item, members of the MPRC noted the following:  the front of the item is blank except for the product names and dosages, and obviously intended for the health care practitioner to write on, while the product information is inscribed on the reverse side and likely would not generally be seen by the health care practitioner.  Members concluded that the primary goal of the item is to serve as a notepad, an item of stationery, featuring reminder advertising for the products in question.

Decision: Contravention of Sections 11.1 and 11.2.

6. Company and Issue:  Eli Lilly Canada Inc. Distribution of items - a badge holder and laniard bearing the inscription "Lilly" repeated several times thereon, bottles of water bearing inscription "Lilly," and a popcorn bag containing inscription "Actos pioglitazone HCI"  - at the annual meeting of a national health care association.

Discussion: Items did not conform to definition of "acceptable service-oriented items."

Decision: Contravention of Sections 11.1 and 11.2.

7. Company and Issue:  GlaxoSmithKline Inc. Distribution of bottles of water bearing product name "Coreg" - at the annual meeting of a national specialty society.

Discussion: Items did not conform to the criterion for "acceptable service-oriented items."

Decision:  Contravention of Sections 11.1 and 11.2.

8. Company and Issue:  GlaxoSmithKline Inc.  Event entitled "Where does Herceptin belong in the Treatment of Breast Cancer?" held October 28, 2002, McLean House, The Estates of Sunnybrook, Toronto, ON.

Discussion: The event was described as "an educational evening" and was convened by GlaxoSmithKline in partnership with a regional cancer centre.  The program provided for Cocktails at 6:30 p.m., a Presentation at 7:00 p.m., and Dinner at 8:00 p.m. The invitation outlined the objective of the event as follows: "To review present Herceptin use and its potential future applications alone and in combination with other agents." Use of a product name was noted, and the invitation provided the name and coordinates of a GSK representative for RSVP purposes. In follow-up correspondence to the MPRC, the company advised that the program was not accredited.

Decision:  As the event was neither accredited, nor met the principles of adult learning, it could not be designated as "educational."  It therefore contravened the final paragraph of Section 4A2.3.

9. Company and Issue:  Janssen-Ortho Inc. Distribution of a "Dear Healthcare Professional" letter, that appeared on the letterhead of a physician, to general practitioners, endocrinologists, psychiatrists, as well as local and national advocacy groups across Canada.

Discussion:  The mailing had been ruled by the Commissioner of the Pharmaceutical Advertising Advisory Board to be in violation of the PAAB's Code of Advertising Acceptance.

Decision:  Contravention of Section 2.2.1 because of PAAB Code violation.

10.  Company and Issues:  Janssen-Ortho Inc. Distribution of the following Advertising/Promotional items:

1. Pharmacy Bulletin Board - "New Pariet, a Proton Pump Inhibitor with full coverage on Ontario Drug Benefit."
2. Abstracts (stand alone APS) Gastroenterology Vol. 118, No. 4 and Gastroenterology 2002: 122 (4 Suppl.): A:199.

3. Reprint Folder "Once-a-day Pariet."
4. Fridge Magnet "Once-a-day Pariet."
5. Notepad "Once-a-day Pariet."

Discussion:  All items had been ruled by the Commissioner of the Pharmaceutical Advertising Advisory Board to be in violation of that organization's Code of Advertising Acceptance.

Decision:  All items contravene Section 2.2.1. because of PAAB Code violation.

11.  Company and Issue: Sanofi-Synthelabo Canada Inc. Distribution to healthcare professionals of Medi-View Express Report "Evolving Concepts in the Treatment and Management of Benign Prostatic Hyperplasia."

Decision: Contravention of Section 2.2.1 because of PAAB Code violation.

12.  Company and Issue:  Schering Canada Inc. Distribution of post-it notes containing inscription "Nasonex - Il est difficile de faire mieux - Aerius - Allergies La Puissance de trois. - Schering Canada Inc."

Discussion:  The item in question measured 4 x 3.  In addition to bearing the inscription noted above, it contained an illustration of the human nasopharynx which, in the opinion of the MPRC, was not easily recognizable. Members concluded that the item is a post-it note, an item of stationery, featuring advertising of the product in question.

Decision: Contravention of 11.1 and 11.2 - distribution of unacceptable service-oriented item.

Appeal:  The Company filed an appeal of the MPRC's decision but subsequently withdrew its decision to appeal.

SUMMARY - REPORT #48