Healthy Skepticism Library item: 16112

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Biron P, Mintzes B, Lexchin J, Gagnon M-A, Wright JM, Hofmann A, Musini V.
IS THE DIOVANTAGE® PATIENT SUPPORT PROGRAM DIRECT-TO-CONSUMER ADVERTISING?
Can J Clin Pharmacol 2009 May 13; 16:(2):285-286
http://www.cjcp.ca/pdf/CJCP08045_e285-e286.pdf

Full text:

Dear Editor,
One of the authors recently filled a prescription in
Montreal for Diovan® (valsartan), an
antihypertensive marketed by Novartis. Inside the
box was the following message printed on the same
sheet of paper as the Consumer information, but in
a larger font:
We are not questioning whether patient
support programs can be helpful in improving
compliance for some specific conditions, but we
are concerned a message about a program
managed directly by a pharmaceutical firm is
within a box containing a prescription medication,
and appearing as an extension of the consumer
product information. We believe that the use of
the name ‘Diovantage®’ for this patient support
program, which combines the brand name
‘Diovan®’ and the word ‘advantage’
demonstrates promotional intent. Advertising of
prescription medicines directly to the public
(direct-to-consumer advertising) is prohibited in
Canada, with the exception of name, price and
quantity, a provision introduced in 1975 to allow
the public to compare product prices in different
pharmacies.1 Health Canada has re-interpreted this
provision to mean that it is illegal to mention the
name of a prescription medication in conjunction
with its indication(s). The ‘Diovantage®’ program
appears to be an attempt to circumvent even this reinterpretation
of Canadian regulations.
The ‘Diovantage®’ information does not
appear in the Part III Consumer information
section of the drug’s Official Product Monograph
dated 14 August 2008, approved by Health
Canada and posted on its website.2 The
Pharmaceutical Advertising Advisory Board
(PAAB), the third party agency that prescreens all
advertising material, did not review the message
because it appeared as the labeling of the drug and
is therefore under the authority of Health Canada.
Nor would the PAAB be required to review any
material that patients request from Novartis as
Health Canada does not view this type of
communication as advertising. (Ray Chepesiuk,
PAAB, personal communication, November 17,
2008).
It is our view that the manufacturer-run
‘Diovantage®’ patient support program is a form
of product advertising under the definition in the
federal Food and Drugs Act: “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.”3
Approved product information that accompanies a
prescription medicine is meant to be nonpromotional.
This is as true for the patient insert
as for prescribing information aimed at health
professionals. The content directed to patients
should be a shortened version of the Product
Monograph in lay language. With more than US
$5 billion in global sales in 2007, Diovan® is not
only the world’s bestselling branded
antihypertensive medicine but also the bestselling
drug for Novartis. The manufacturer claims that
“Patient Offer! DioVantage® Patient support
program. A heart-healthy advantage for you.
Motivational! Inspirational! Educational!
The DIOVANTAGE® Program works with your
doctor to deliver the facts you need to know to keep
your blood pressure under control.
Free! Exclusively for People on DIOVAN®/DIOVANHCT
®
Featuring tips, advice, recipes, medical news,
information covering nutrition, diet, fitness, stress,
your medication and other key topics sent directly to
you. Make Diovantage® your advantage. Enroll
today! Simply complete, sign and mail in a stamped
envelope to Diovantage®, POB 5314, St-Laurent,
Quebec, H4L 4Z9 or fax back this card to 1 888 422
4242 or call 1 866 601 4264
Please print: Mr./Mrs./Miss, name, address, city,
province, postal code, language preference
(English/French); signature
Please enroll me in the DIOVANTAGE® Program
without delay. I understand that all materials are
free of charge and I may cancel my membership at
any time.
We are not questioning whether patient
support programs can be helpful in improving
compliance for some specific conditions, but we
are concerned a message about a program
managed directly by a pharmaceutical firm is
within a box containing a prescription medication,
and appearing as an extension of the consumer
product information. We believe that the use of
the name ‘Diovantage®’ for this patient support
program, which combines the brand name
‘Diovan®’ and the word ‘advantage’
demonstrates promotional intent. Advertising of
prescription medicines directly to the public
(direct-to-consumer advertising) is prohibited in
Canada, with the exception of name, price and
quantity, a provision introduced in 1975 to allow
the public to compare product prices in different
pharmacies.1 Health Canada has re-interpreted this
provision to mean that it is illegal to mention the
name of a prescription medication in conjunction
with its indication(s). The ‘Diovantage®’ program
appears to be an attempt to circumvent even this reinterpretation
of Canadian regulations.
The ‘Diovantage®’ information does not
appear in the Part III Consumer information
section of the drug’s Official Product Monograph
dated 14 August 2008, approved by Health
Canada and posted on its website.2 The
Pharmaceutical Advertising Advisory Board
(PAAB), the third party agency that prescreens all
advertising material, did not review the message
because it appeared as the labeling of the drug and
is therefore under the authority of Health Canada.
Nor would the PAAB be required to review any
material that patients request from Novartis as
Health Canada does not view this type of
communication as advertising. (Ray Chepesiuk,
PAAB, personal communication, November 17,
2008).
It is our view that the manufacturer-run
‘Diovantage®’ patient support program is a form
of product advertising under the definition in the
federal Food and Drugs Act: “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.”3
Approved product information that accompanies a
prescription medicine is meant to be nonpromotional.
This is as true for the patient insert
as for prescribing information aimed at health
professionals. The content directed to patients
should be a shortened version of the Product
Monograph in lay language. With more than US
$5 billion in global sales in 2007, Diovan® is not
only the world’s bestselling branded
antihypertensive medicine but also the bestselling
drug for Novartis. The manufacturer claims that
Diovantage®, also known as “CV Success
Zone®”, improves compliance with Diovan®
prescriptions.4 In Canada this claim is based on an
uncontrolled observation study where only 15,200
out of an enrolled population of 33,718 (45%) were
considered “evaluable”.5 The program, however,
also increases sales: Novartis claims that such
support programs are key drivers behind the 19%
yearly sales growth for Diovan®.6
In France, the Ministry of Health recently
received a report from its Inspection Committee,
which recommended the prohibition of any direct
or indirect relations between firms and patients,
including support programs. The committee’s
conclusions are unambiguous: such support
programs are clearly commercially motivated.7
The question is not whether valsartan in
particular, or ARBs in general, are useful in some
patients. These drugs are prescribed daily and have
not been the subject of strong safety warnings. The
question is whether a consumer information sheet
in a box containing a prescription drug should be
used for product promotion and gathering private
information.