Healthy Skepticism Library item: 15770

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

Silversides A.
Charter challenge of ban on direct-to-consumer advertising to be heard by Ontario court in mid-June
CMAJ 2009 Jun 11; 181:(1):
http://www.cmaj.ca/earlyreleases/091050.pdf

Full text:

CanWest Mediaworks Inc. has
been granted an indefinite adjournment
in a landmark Canadian
Charter of Rights and Freedoms
challenge case about direct-to-consumer
prescription drug advertising
that was scheduled to be heard in Ontario’s
Superior Court of Justice from
Jun. 15-19.
Andrew Lokan, a lawyer for the financially
troubled media giant, declined
comment, but promised a public
statement Jun. 12.
“CanWest is teetering on the verge
of bankruptcy and has been for some
time,” said Steven Shrybman, a
lawyer for a coalition of public interest
groups that was granted intervener
status in the case. He said the company
should have pulled the plug on
this “ill-conceived litigation” months
ago instead of “at the 11th hour,” and
spared the federal government and the
interveners the expense of preparing
the court application.
In submissions made to the court
earlier this year, the nub of the debate
involved 2 very different takes on
Canada’s law than bans direct-to-consumer
advertising of prescription drugs.
While Canwest will be free to revive
the case at some future date, Shrybman
says the coalition believes the case
“has no merit and should be abandoned
before any additional and needless litigation
expenses are incurred.”
Direct-to-consumer advertising is
banned or strictly limited in all Western
countries except New Zealand and the
United States, where drug companies
spend about US$4-billion annually in a
bid to boost sales.
The charter challenge was launched
in December 2005. Since then, the affidavits
of 18 expert witnesses have been
filed with the court and, in an unusual
move, the court granted intervener status
to a broad coalition of public interest
groups, including the Canadian Federation
of Nurses Unions, Women and
Health Protection and the Canadian
Health Coalition.
If the ban was lifted, the advertising of
prescription drugs – and sales of such
drugs – would significantly increase, the
parties agree. But opinion differs on the
impact of this change.
Media giant CanWest argues in its
submission that the section of the Food
and Drug Act that prohibits advertising
to the public of a drug as a treatment or
cure for certain diseases or disorders – so called “product specific” or “product
claim” ads – contravenes a Charter
provision that guarantees “freedom of
thought, belief, opinion and expression,
including freedom of the press and
other media of communication.”
The ban also limits information that
patients “have a right to receive” and is
paternalistic, anachronistic and too
broad, according to CanWest’s brief.
But the Attorney General of
Canada’s submission states that the
heart of the case is a balance between
“the commercial interests” of Can-
West and the societal interest of protecting
Canadians, public health and
the health care system from the harms
of direct-to-consumer advertising of
prescription drugs. The ban is justified
by section 1 of the Charter, which
guarantees rights and freedoms “subject
only to such reasonable limits
prescribed by law as can be demonstrably
justified in a free and democratic
society.”
The Attorney General argues that
CanWest doesn’t provide evidence that
its own “expressive rights” have been
infringed by the ban and that it would
be “more appropriate” for the pharmaceutical
companies themselves to challenge
the advertising ban.
For its part, the intervener coalition
states that the ban restricts “commercial
expression aimed at manipulating
the public and patients about a complex
and highly-specialized subject
matter, namely prescription drugs, and
as a result protects the Canadian public
in an area in which they are particularly
vulnerable.”
Both the coalition and the federal
government state that CanWest’s only
concern is that the ban stands in the
way of it selling advertising. The media
company would not be “accountable
for any harm that branded or
product specific promotional advertising
would cause,” the intervenor coalition
contends.
CanWest argues that Canadian media
“are penalized” because the federal
government allows Canadians “to be
bombarded” with prescription drug advertisements
in cross-border United
States media outlets.
As well, CanWest notes that the government
does allow some prescription
drug company advertisements to be
broadcast by Canadian media. As a re
sult the system is “patchwork, irrational
and antiquated,” its submission states.
Customized Canadian drug company
ads that dodge the letter of the law
have proliferated over the past decade.
They generally fall into 2 types: “Help
seeking” ads mention a condition, but
not the drug that treats it (reader/viewers
are urged to contact their doctor/call
a telephone number/visit a website); or
“reminder ads” that mention a prescription
drug but not its purpose.
These ads began appearing following
a Health Canada policy interpretation
of a regulation, dating back to the
1970s, intended to allow pharmacists to
advertise drug prices.
For its part, the intervener coalition
submission contends that Health
Canada is lax in enforcement and permits
Canadian drug company advertisements
that “clearly extend well beyond”
the limits permitted in regulations.
An example is the advertising campaign
for Diane-35, a drug that is approved
only for the treatment of severe
and nonresponsive acne. A campaign of
reminder television and print ads implied
that the drug is a contraceptive and
it was subsequently widely prescribed
for that purpose. Meanwhile, Health
Canada has issued safety warnings that,
used as a contraceptive, the drug is 4
times more likely to cause potentially fatal
drug clots than approved contraceptive
drugs.
It also is “a matter of administrative
policy and operation practice” that US
drug company cross-border advertising
is not restricted, even though it is not
permitted in law. However, this lack of
enforcement is irrelevant, the coalition
argues. The “constitutional validity” of
the Canadian ban on direct-to-consumer
redrug
advertising “does not and cannot”
be decided on how it is enforced or administered
by the government.
Direct-to-consumer advertising has
been the subject of ongoing review and
consultation at Health Canada and
“views remain polarized,” the federal
submission notes. In general, stronger
prohibitions are favoured by “academia,
patient groups, consumer groups
most health professional and individuals,”
while drug companies and media
supported more advertising.
The intervener coalition states that
prescription drug advertising disproportionately
affects women, who are more
often the target of such ads and, in their
care-giving roles in families, often make
health care decisions for their children
and other relatives. Women also live
longer and have greater exposure to
medicines for chronic diseases, the interveners
state.
Yet the advertisements “fail to alert”
women to the fact that clinical evidence
of how a medication, such as statin
drugs, will affect women is often limited.
Meanwhile, most drugs selected
for such advertising in the United
States are newer, costlier drugs that offer
no, or only marginal, benefit over
existing drugs, and lack an extensive
safety profile because they have not
been fully tested on broad populations,
the submission adds.
The Canadian Medical Association,
Canadian Pharmacists Association and
the Health Council of Canada are on
record as opposing direct-to-consumer
advertising of prescription drugs but
are not members of the intervener
coalition.