A pair of television advertisements for Merck's anti-inflammatory drug rofecoxib (Vioxx) are being examined by the Food and Drug Administration to determine whether they violate current guidelines for direct to consumer drug advertising.
In 1985 the FDA reversed its long standing policy of prohibiting direct to consumer drug advertising, and in August 1997 it liberalised its policy on such advertising considerably. Drug companies are now allowed to advertise their products directly to consumers, as long as they state the indications for using the drug and disclose the major health risks and side effects associated with it.
The ruling allows drug companies to refer consumers to further information that is made available on websites, on free of charge telephone numbers, or in printed references and recommends that patients be directed to doctors for more information. Another requirement is that the advertisements must not be misleading.
The FDA also allows two other types of drug marketing advertisements: "help seeking advertisements" and "reminder advertisements." Help seeking advertisements focus on a disease but don't name a specific drug and usually end with a recommendation to "see your doctor." Reminder advertisements may use a product's name but cannot give details of its benefits or risks.
Merck's questionable advertisements feature Olympic figure skater Dorothy Hamill as a spokeswoman for rofecoxib, a cyclo-oxygenase-2 selective non-steroidal anti-inflammatory drug.
The advertisements are being scrutinised because they don't mention the risks and side effects of the drug. Also, because the advertisements are so similar visually, the FDA argues that if they are run back to back they would be considered one advertisement and could constitute a violation of FDA rules. However, if there is a clear separation of the two advertisements, they may fall under the help seeking and reminder advertisement rules.
Both carry the same background music and scenery—an ice rink surrounded by snowy mountains. In both, Hamill is seen lacing up her skates and skating around the ring.
One advertisement mentions osteoarthritis but not the drug being advertised. A voiceover by Hamill intones: "I love to skate at that time of day, but it's also the time when the pain and stiffness of osteoarthritis can be at their worst."
An authoritative voice then addresses viewers: "Ask your doctor about ways to help relieve the pain of osteoarthritis." The advertisement then refers viewers to a free telephone number, which includes the Merck name, for more information.
The other advertisement mentions the drug's name but not arthritis. Over the same visuals as used in the first advertisement, a voice advises viewers, "Ask your doctor about Vioxx, a prescription medicine from Merck. And find out if Vioxx is right for you." Then it lists a free telephone number that includes the Vioxx name, displaying it in the same position and typeface as the free Merck number shown in the first advertisement.
Drug companies' spending on direct to consumer advertising has skyrocketed since the liberalisation of the FDA policy. In 2000, $2.5bn (£1.6bn; €2.5bn) was spent on marketing drugs directly to consumers, an increase of 35% on the previous year, according to research by the Kaiser Family Foundation, an independent healthcare charity.
Rofecoxib is one of the most heavily advertised drugs. An estimated $135m was spent on advertising the drug to consumers in 2001 alone, according to data compiled by Competitive Media Reporting, a data research group located in New York City.
Direct to consumer advertising itself has remained controversial, with advocates promoting it as a way to empower patients, while detractors point out that it raises drug costs and puts pressure on doctors to prescribe unnecessary drugs to satisfy their consumers.
