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 specific medicines.

Members of EFPIA include U.S.-based companies such as Amgen, Bristol-Myers Squibb, Eli Lilly, Johnson and Johnson, and Pfizer.

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 recommended.

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>.▪