Although direct-to-consumer (DTC) advertising of prescription drugs is
legal in only the United States and New Zealand among industrialized
countries, proposed legislation in the European Union (EU) and Canada may open
the door to this type of marketing. Meanwhile, spending on DTC advertising in
the U.S. market is expected to remain flat or decline in the near future.
The European Commission, the executive branch of the EU, recently announced
a proposed law that included provisions to lift the current ban on DTC
advertising and allow drug companies to provide prescription drug information
to the public through television, radio, and print media, the U.K. newspaper
the Guardian reported on April 8. The report cited concerns and
objections from consumer groups about the proposal.
In an April 7 press release from the European Federation of Pharmaceutical
Industries and Associations (EFPIA), which represents 43 major pharmaceutical
companies and industry associations in 32 countries, stated that it was not
pushing for legalizing DTC advertising in Europe. In fact, the federation's
position is that "such mass media would not be an appropriate means for
the industry to communicate information on specific prescription medicines to
European citizens," Arthur Higgins, president of EFPIA and CEO of Bayer
Healthcare AG, said in the release.
Instead, EFPIA proposes a model that will actively disseminate general
health information on diseases and prevention to the public without mentioning
Members of EFPIA include U.S.-based companies such as Amgen, Bristol-Myers
Squibb, Eli Lilly, Johnson and Johnson, and
The Pharmaceutical Research and Manufacturers of America (PhRMA), the
drug-industry trade group, however, considers DTC advertising beneficial to
patients and the public. In a voluntary "Guiding Principles"
document, PhRMA states that "DTC advertising of prescription medicines
can benefit the public health by increasing awareness about disease, educating
patients about treatment options, motivating patients to contact their
physicians and engage in dialogue about health concerns, increasing the
likelihood that patients will receive appropriate care for conditions that are
frequently underdiagnosed and undertreated, and encouraging compliance with
prescription drug treatment regimens."
It is not surprising that these two industry organizations with overlapping
members take apparently different positions on DTC advertising, then-APA
President-elect Nada Stotland, M.D., told Psychiatric News. She
pointed out that the European health care and drug pricing systems are very
different from those in the United States.
"Physicians behave differently in these systems," she
explained. "Companies have to charge less for prescription drugs in
other countries." Therefore, the return from DTC advertising may not be
worth the investment. In the United States, however, "there are few
settings in which it actually costs the doctors to prescribe more expensive
drugs, except in public health care and a few managed care settings like
Kaiser," Stotland said, referring to the third-party-payer system of the
U.S. health care market, in which most prescribers have no financial
incentives to limit prescription drug costs.
Meanwhile a provision in a proposed amendment to the Canadian Food and
Drugs Act may legalize DTC advertising by pharmaceutical companies through
television, radio, and print media, the Globe and Mail newspaper
reported on April 11.
The current act does not allow drug advertisements to link therapeutic
indications to a drug's name. The proposed law will place the power of
regulating—and possibly greenlighting—DTC advertising in the hands
of government agencies under the order of the cabinet, thus bypassing debates
and voting in the Parliament.
Critics condemned this proposal, warning of increased health care expenses
if the ban is lifted. The health minister and an advisor for Health Canada,
however, denied that the government agency has plans to allow DTC advertising,
according to the newspaper.
A recent study in the April 24 New England Journal of Medicine
found dramatic differences in prescribing patterns of U.S. and Canadian
physicians despite their access to similar clinical evidence. The
controversial cholesterol-lowering drug ezetimibe (brand name Zetia in the
United States and Ezetrol in Canada; in combination with simvastatin in
Vytorin) was prescribed five times more frequently in the United States than
in Canada in 2006, and expenditures for ezetimibe per 100,000 population were
four times higher in the United States, the study concluded.
The authors cited the different availability of DTC advertising as one of
the contributing reasons. "In the United States, in 2007, more than $200
million was spent on direct-to-consumer advertising for Vytorin alone, which
probably had an effect on U.S. sales of ezetimibe," they wrote.
Sales of Zetia and Vytorin totaled $5.2 billion in 2007, according to
Bloomberg News, but the forecast for its sales has darkened since
January, when a large, company-sponsored study revealed that Vytorin appears
to be no more effective in preventing atherosclerosis progression than
simvastatin alone. DTC advertisements for Vytorin have since been discontinued
by its makers, Merck and Schering-Plough.
In the United States, annual spending by the pharmaceutical industry on DTC
advertising grew from $1.1 billion in 1997 to $4.2 billion in 2005, according
to a report released by the Government Accountability Office (GAO) in 2006.
The GAO criticized the Food and Drug Administration for a lack of efficiency
and effectiveness in blocking DTC materials that violated regulations.
The GAO report noted that DTC advertising may increase drug spending and
utilization "by prompting consumers to request the advertised drugs from
their physicians, who are generally responsive to these requests." It
also acknowledged positive effects of DTC advertising such as encouraging
patients' communication with their physicians.
One upside of DTC ads for antidepressants and antianxiety drugs is that
they have helped reduce the stigma of mental illness, Stotland noted.
Nonetheless, "drug ads can be misleading and tend to portray people as
being gloriously happy, which may feed into the misconception that
antidepressant drugs are 'happy pills' when they merely help patients return
the normal state."
"Physicians have to negotiate with patients. They have to take the
time to conduct a thorough examination, reach an accurate diagnosis, and
discuss the appropriate treatments with the patient," Stotland
In addition to the criticized DTC promotion of Vytorin, Pfizer was recently
investigated by the U.S. House of Representatives for the portrayal of the
spokesperson Robert Jarvik, M.D., in its DTC advertising campaign for
atorvastatin (Lipitor). The advertisements implied that Jarvik is a
cardiologist (he is not, despite having invented the artificial heart) and
showed him rowing vigorously in a television commercial (he does not row). The
promotional materials were eventually pulled.
To control health care costs, a number of state legislatures are exploring
ways to limit or counter the effect of pharmaceutical marketing, according to
a report by the National Conference of State Legislatures (NCSl) posted on its
Web site in March.
Facing increased media and regulatory scrutiny as well as profit
challenges, U.S. pharmaceutical companies will likely restrict their budgets
for DTC advertising in 2008, a survey of industry, advertising, and consulting
firms found. The survey was conducted by Cegedim Dendrite, a sales and
marketing company for pharmaceutical companies, and the results were released
in March. More than half of the survey respondents said they did not expect to
see an increase from the previous year in DTC advertising expenditures.
The GAO report on FDA regulation of DTC advertisements is posted at<www.gao.gov/new.items/d0754.pdf>.
The NCSL report on state legislation related to DTC advertising is posted at<www.ncsl.org/programs/health/Rxads.htm>.▪