[e-drug] DTCA and Canada 2

[e-drug@healthnet.org]

E-drug: DTCA and Canada 2
---------------------------------------------

2.  Commentary:   Supported by an unrestricted educational grant
[Copied as fair use]

Ray Chepesiuk
CMAJ 2003;169 421-422
http://www.cmaj.ca/cgi/content/full/169/5/421?etoc

Mr. Chepesiuk is Commissioner of the Pharmaceutical Advertising 
Advisory Board (PAAB), Pickering, Ont.

Pharmaceutical companies use various means to communicate messages 
about their products. They produce advertisements and original 
research articles that are published in peer-reviewed journals, they 
use direct advertising through a variety of media, and they produce 
"educational" meeting reports and newsletters that appear in 
publications or are sent directly to physicians. The purpose of this 
article is to increase awareness of trends in this third category: 
some of these meeting reports and newsletters may in fact be 
advertising disguised as educational material.

Material in the first 2 categories goes through independent 
assessment before reaching its intended audience. Prescription drug 
advertising is for the most part overseen by an autonomous 
organization, the Pharmaceutical Advertising Advisory Board (PAAB). 
PAAB is endorsed by Health Canada, the ultimate legal authority on 
drug advertising in Canada, and the 2 organizations have a working 
relationship. Advertisements published in medical journals are 
independently assessed by PAAB, as is direct advertising material 
delivered to physicians electronically, through the mail or by hand 
by company representatives. Original research articles that appear in 
medical journals undergo the independent scrutiny of the peer review 
process. Many journals have endorsed the policies of the 
International Committee of Medical Journal Editors1 to ensure that 
the involvement of the organizations supporting a research study is 
clearly described.

The situation is less clear-cut for material in the third category. 
Educational articles, meeting reports and newsletters sponsored and 
distributed by the pharmaceutical industry can help physicians keep 
abreast of current medical information. They promote awareness of 
recent consensus statements and provide information on new classes of 
therapeutic products, the latest safety data and new treatment 
options. However, this type of material is often not externally 
vetted. It is important that physicians are able to determine whether 
what they are reading is intended to be advertising.

Advertising is defined in the Food and Drugs Act as "any 
representation by any means whatever for the purpose of promoting 
directly or indirectly the sale or disposal of any food, drug, 
cosmetic or device."2 For example, if a pharmaceutical company 
sponsors the distribution of an article that describes a meeting 
presentation of clinical trial results involving one of their 
products, the material would fit the definition of advertising. 
Advertising regulations cover material such as newsletters and 
quasi-scientific publications that promote sales directly or 
indirectly.

If this type of material is classified as advertising according to 
the Food and Drugs Act, and if advertising is independently reviewed 
by PAAB, why is there a problem? In 1996, PAAB instituted its 
Guideline on Educational Meeting Reports,3 which exempts educational 
meeting reports from being classified as advertising and thus exempts 
them from PAAB review. This guideline was instituted so that 
physicians could receive objective and balanced information about 
therapies from presentations given at accredited continuing medical 
education meetings in a timely manner. Health Canada and PAAB require 
independence of the process and objectivity of the contents for 
material to qualify for this exemption; publishers of these materials 
are expected to act responsibly.

PAAB will not approve off-label claims, claims based on poor 
evidence, safety claims that lack balance or unfair comparisons with 
competitors' products. Thus, the appeal of an exemption that allows 
publishers to bypass PAAB review is clear. Many meeting reports and 
educational newsletters are of high quality, but I have also seen 
reports based on preliminary trial data, incomplete scans of the 
literature, unfair comparisons, suggestions for off-label uses and 
inappropriate descriptions of safety measures.

What can physicians do? Physicians and scientists who are asked to 
contribute to a medical newsletter or meeting report should be 
cautious. Pharmaceutical companies want physicians to be involved in 
creating these documents to give the material credibility, and often 
pay well for participation. To meet the exemption's requirement for 
independence of the process, participating physicians must be truly 
independent of the sponsoring company, that is, they would have to 
enter into a contract with a health care organization that is not 
considered to be an agent of the company. If physicians are hired to 
participate directly by the sponsoring pharmaceutical company or by a 
commercial publisher representing that company, the resulting 
document is usually not considered to be independent by PAAB.

Physicians who are invited to participate in an educational project 
should obtain the name of the sponsor from the publisher or 
organization that has approached them, and they should ask whether 
the project is considered to be advertising by PAAB. If it is, then 
the material should be clearly identified as advertising and it 
should be reviewed by PAAB. If the originator of the project 
indicates that the material constitutes continuing medical education 
because it is "supported by an unrestricted educational grant," then 
it should meet all of the requirements of continuing medical 
education material.4,5,6 If it is not clear to which category the 
material belongs, contributors should be aware that it will most 
probably be perceived to be advertising. Remember, if a 
pharmaceutical company sponsors the distribution of material 
containing information about its products, the material is likely 
considered by law to be advertising, despite the involvement of 
physicians or scientists and the claim that the project was funded by 
an unrestricted grant.

Physicians who receive these types of material should also exercise 
caution. The PAAB logo should be displayed on all advertising 
material that it has approved. If the logo is not displayed on 
material that appears to be advertising, readers are encouraged to 
send a letter of complaint with the original material and a 
description of how they received the material to the PAAB 
Commissioner, Suite 200, 375 Kingston Road, Pickering ON L1V 1A3. 
Reports on previous complaints can be found in the quarterly PAAB 
Update, which can be found in the Newsletters section of the PAAB Web 
site (www.paab.ca).

ß See related articles pages 405 and 425

Footnotes
This article has been peer reviewed.

Competing interests: Mr. Chepesiuk is employed by PAAB.

Correspondence to: Mr. Ray Chepesiuk, Commissioner, Pharmaceutical 
Advertising Advisory Board, Suite 200, 375 Kingston Rd., Pickering ON 
L1V 1A3; fax 905 509-2486; commish@paab.ca

References
1.International Committee of Medical Journal Editors. Uniform 
requirements for manuscripts submitted to biomedical journals. 
Updated 2001. Available: www.icmje.org (accessed 2003 July 30).
2.Departmental consolidation of the Food and Drugs Act and of the 
Food and Drug Regulations with amendments to Jan 1, 2003. Ottawa: 
Health Canada; 2003. Available: 
www.hc-sc.gc.ca/food-aliment/friia-raaii/food_drugs-aliments_drogues/act-loi/pdf/e_a-contnt.pdf 
(accessed 2003 July 30).
3.Pharmaceutical Advertising Advisory Board. Guideline on educational 
meeting reports. Pickering (ON): The Board; 1996. Available: 
www.paab.ca/eduguide_en.html (accessed 2003 July 30).
4.College of Family Physicians of Canada. MAINPRO-M1 and MAINPRO-C 
accreditation criteria for courses, conferences and workshops. 
Available: www.cfpc.ca/cme/mainpro/maintenance/8-accredM1MC.asp 
(accessed 2003 July 30).
5.The Royal College of Physicians and Surgeons of Canada. Guidelines 
for accredited providers of CPD activities. Available: 
www.rcpsc.medical.org/english/maintenance/providers/index.php3 
(accessed 2003 July 30).
6.Canada's Research-Based Pharmaceutical Companies. Code of marketing 
practices. Available: 
www.canadapharma.org/Industry_Publications/Code/Code_e.pdf (revised 
2003 jan) (accessed 2003 July 30)

--
To send a message to E-Drug, write to: e-drug@healthnet.org
To subscribe or unsubscribe, write to: majordomo@healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@healthnet.org
Information and archives: http://www.essentialdrugs.org/edrug