Healthy Skepticism Library item: 7393

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

Editoral
The direct-to-consumer advertising genie
The Lancet 2007 Jan 6-12; 369:(9555):1
http://www.sciencedirect.com/science/article/B6T1B-4MRGVD0-1/2/460e79d5839e4f0abe42081675f6f509

Abstract:

European commissioners are considering proposals to loosen Europe’s ban
on direct-to-consumer advertising for prescription drugs. But before
they proceed, they should look carefully at the US experience.
Direct-to-consumer advertising has been allowed in the USA since 1997.
The pharmaceutical industry claims the advertisements educate patients
about health, inform them about new treatments, and encourage them to
talk to their doctors about important health concerns. Opponents,
however, argue the advertisements are simply that: advertisements, most
of which push expensive new drugs even when less expensive and often
safer treatments, or even no treatment at all, would suffice.

A new US government report suggests such concerns are warranted. The
report was published by the US Government Accountability Office.

http://www.sciencedirect.com/science?_ob=RedirectURL&_method=externObjLink&
_locator=url&_cdi=4886&_plusSign=%2B&_targetURL=http%253A%252F%252Fwww.gao.g
ov%252Fcgi-bin%252Fgetrpt%253FGAO-07-54

GAO), a non-partisan investigative and research agency of the US
Congress. The report reviews direct-to-consumer advertising in the USA
and examines how well the US Food and Drug Administration (FDA) oversees
these advertisements. The investigators found the oversight was lax. But
their report also raises questions about the value of direct-to-consumer
advertising and shows just how hard it is to regulate once this genie is
out of the bottle.

The investigators showed that from 1997 to 2005, industry spending on
direct-to-consumer advertising grew on average nearly 20% per year,
twice as fast as spending on drug promotion to doctors, reaching US$4·2
billion in 2005. By comparison, industry spent $31·4 billion on research
and development, according to the GAO report.

More than 50% of the direct-to-consumer spending went to advertisements
for just 20 drugs, most for chronic conditions such as hyperlipidaemia,
asthma, and allergies. Not surprisingly, these are the same drugs that
drug companies are promoting directly to doctors with advertising in
medical journals, drug-representative visits, and free samples. It’s a
smart dual-pronged strategy, because a doctor is more likely to provide
a particular drug when a patient asks for it and when the doctor has
free samples on hand.

Now, this is not to say that direct-to-consumer advertising does not
help some patients. In many cases, patients may have been well served by
advertisements that led them to discuss their concerns with their
physicians. But the primary purpose of direct-to-consumer advertising
remains clear: to sell lucrative, on-patent, brand-name drugs. Claims to
the contrary just do not pass the straight-face test.

How well, then, does the FDA oversee this advertising? Not well, the GAO
showed. Under the law, advertising materials must contain a “true
statement” of information that includes a brief summary of
effectiveness, side-effects, and contraindications. Broadcast materials
may present only major effects and contraindications, but must provide
information about where consumers can get more details. When material is
shown to be in violation, FDA officials issue a regulatory letter that
might call for the advertisement to be stopped or, in more serious
cases, for new advertisements to correct misinformation that may have
been disseminated.

In general, the FDA only reviews material after it is disseminated,
although in some cases companies bring their materials to the agency for
comment before dissemination. Because the FDA can review only a small
proportion of advertising put out each year, FDA officials told the GAO
investigators that they used informal criteria to select what to review.
But the GAO investigators showed that the FDA had no written
documentation detailing these criteria, no system for applying the
criteria, and no record for tracking what it had reviewed. In addition,
the FDA issued relatively few regulatory letters, between eight and 11
per year between 2002 and 2005. However, once the FDA began drafting a
letter it took on average 4 months before it was issued. In many cases,
by that time the advertising campaigns had often run their course.

Part of the FDA’s performance is probably due to the influence of an
industry-friendly administration that has made its antipathy towards
government regulation clear. This should serve as a warning to European
regulators that unless done very carefully, relaxation of
direct-to-consumer advertising regulations risks creating a tidal wave
of marketing that will be difficult to control.

It would be better to fund independent information sources, free of
industry influence, to provide the public with unbiased evidence-based
information. If industry truly wants to inform the public, it should
supply no-strings-attached funds to support such efforts. Even a small
portion of the $4·2 billion being spent each year in the USA on
direct-to-consumer advertising would do nicely.