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特集：医療英語 > 第 2 回：The Pharmaceutical Industry and DTC* Advertising: What can Japan and Europe Learn from the US?
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* Direct-to-consumer advertising
Whether watching the evening news or an afternoon soap opera, advertisements for prescription drugs to treat high blood pressure, high cholesterol, type 2 diabetes, erectile dysfunction, overactive bladder, depression and other common ailments and diseases fill commercial breaks on U.S. television networks. Since the US Food and Drug Administration (FDA) legalized direct-to-consumer (DTC) broadcast advertising in 1997, Americans have been bombarded by advertisements for prescription drugs that treat all kinds of physical and psychological ailments.
What is DTC advertising for pharmaceuticals and what effect has it had on Americans' health and the pharmaceutical industry? In DTC advertising, prescription drug advertisements are aimed directly at the consumer. Traditionally, pharmaceutical companies promoted their drugs to doctors and medical professionals only. Although the FDA legalized DTC advertising in 1985, advertisements increased substantially after 1997, when the FDA allowed companies to name both the drug and the disease it treated in the same advertisement with just a brief summary of the possible side-effects instead of having to list every possible side-effect. According to IMS Health, pharmaceutical companies' spending on DTC advertising in the US increased from $75 million in 1996 to $2.5 billion in 2000.
Experts and analysts have mixed opinions regarding the effects of DTC advertising on Americans' health. According to FDA survey results released in 2003, DTC ads help educate patients about their health problems and provide greater awareness of treatments. The 500-physician survey indicated that when a patient asked about a drug, 88 percent of the time they had the condition that the drug treated. Furthermore, 80 percent of physicians believed patients understood what condition the drug treats. However, approximately 75 percent of physicians believed that DTC ads lead patients to believe that the drug works better than it does, and many physicians felt some pressure to prescribe something when patients mentioned DTC ads.
All experts agree that drugs carry risks, and that each drug's benefits must be weighed against its risks. However, some observers believe that due to DTC advertising, new drugs are used by more people faster than ever before, creating a potential problem if the drugs have unanswered safety questions. The FDA has been criticized for being negligent in its role of policing drug safety, but its recent warning to Pfizer that its DTC advertising made "misleading" safety and efficacy claims about cox-2 inhibitors Celebrex® and Bextra® indicates that the agency is becoming stricter.
Critics blame DTC advertising for contributing to the high cost of American healthcare, in which prescription drugs are the fastest-growing part of total healthcare costs. For example, cox-2 inhibitors such as Merck's Vioxx® and Pfizer's Celebrex® were advertised for all patients, regardless of the fact that cheaper retail medications such as Ibuprofen work just as well for most patients. The US pharmaceutical industry maintains that DTC advertising increases patient awareness of innovative treatments and improves compliance.
What does the future hold for DTC advertising? Will it be introduced in Europe and Japan? In the US, the FDA commissioned three surveys to help it decide whether DTC advertising rules need to be changed. Health authorities in Japan and Europe are closely watching the effects of DTC advertising in the US. It is interesting to note that although pharmaceutical companies publicly support DTC advertising in the US, top executives from GlaxoSmithKline and AstraZeneca recently told a British parliamentary committee that they did not believe that it was appropriate to allow pharmaceutical companies to advertise medicines in public places in the UK. It appears that discussions between pharmaceutical companies and health authorities regarding DTC advertising will continue. Hopefully each country will find a solution that is culturally appropriate and that will provide the benefits of DTC advertising, such as increasing people's awareness of and accountability for their health.