E-DRUG: Laws regulating drug promotion (2)

E-DRUG: Laws regulating drug promotion (2)
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Dear E Druggers:
                                                            
The problems raised by Gerrit Weeda are very real ones that
have yet to be adequately addressed anywhere as far as I know.
Here in Canada the Canadian Medical Association has guidelines
that supposedly cover these situations, but since the CMA is a
voluntary organization it has no enforcement powers and can do
nothing when violations are detected. Furthermore, the CMA has
not made any real effort to initiate a discussion about the
guidelines beyond distributing them as an insert in the Canadian
Medical Association Journal. The College of Physicians and
Surgeons of Ontario, the licensing body for physicians in the
province of Ontario, has adopted the CMA guidelines as the
policy of the College but likewise has done nothing about
trying to initiate any widespread debate/discussion about
the guidelines and when they are violated by a drug company is
powerless to act since it has jurisdiction only over the actions
of physicians. This powerlessness has become clear just this week
when it was revealed that Bristol Myers Squibb was planning to
sponsor a weekend on AIDS therapy at a very plush resort in
Ontario. A physician complained about this to the College, which
did not know about the conference and even after it did had no
power to act. (Subsequent to the publicity BMS changed
the venue to a downtown hotel in Toronto.)
                                                                                                                 
The Pharmaceutical Manufacturers Association of Canada also has
a set of guidelines but these are only enforced through a
complaints mechanism, not through any active monitoring of
compliance. The sanctions for violating the code are extremely
weak and the reporting about violations of the code is done in
a very nontransparent manner.
                                                                                                                 
I agree with Rizwan that actions by the U.S. FDA can be more
severe than those of industry associations but at the same time
the FDA is very underresourced in its ability to monitor
promotional activities. Furthermore, how aggressive the FDA is
in controlling promotion is dependent on the philosophy of the
head of the FDA. David Kessler, the past head, was quite
quite concerned about promotion and gave it a high priority,
but the person before him, Frank Young (I think) was much more
pro-industry and did little about promotional excesses.
                                                          

From the point of view of health care providers-doctors,

pharmacists and others-I think that an educational approach is
likely to be much more productive than a punitive approach,
with the realization that education around these issues will
probably take some time to produce results especially as many
doctors see no problem in accepting whatever largesse the drug
companies are willing to send their way.
                                                             
In order to police the activities of industry my approach is
an independent body, but one that has its basis in legislation
so that compliance with its code and its ability to levy and
enforce sanctions has a legal basis. This body should operate
in a transparent manner and should have representation from a
wide range of groups including consumers. Although the members
would be appointed by government, the appointments should come
from a short list submitted by the organizations that will be
represented on the board of such an agency. That would limit
the government's ability to appoint people with a pro-industry
bias. The agency should prescreen promotion where possible
(e.g. ads, direct mailings, etc.) and where this is not
possible (e.g. visits by sales representatives, company
activities at continuing medical education events) compliance
should be proactively monitored rather than just relying on
complaints. Finally, the resources to run such an agency should
come from tax or levy on promotional activities by companies,
e.g. so many dollars per ad screened, so many dollars per 100
visits by sales representatives.

Joel Lexchin MD
121 Walmer Rd.
Toronto, Ontario
CANADA M5R 2X8
Phone: (416)-964-7186
Fax: (416)-923-9515
email: joel.lexchin@utoronto.ca
  
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