Anyone who's watched TV in the last few months has probably seen the ads.
A kindly "doctor," Robert Jarvik, inventor of the artificial heart, tells viewers about the benefits of Lipitor, the cholesterol-lowering medication. The ubiquitous commercial, along with previous ads, helped make Lipitor the best-selling drug in the world, with almost $13 billion in sales in 2006.
Those ads, and their use of celebrity endorsers, like Jarvik, are now being investigated, for potentially misleading viewers, by Reps. John D. Dingell, D-Mich., and Bart Stupak, D-Mich.
Critics of the drug industry have long claimed that such ads emotionally manipulate viewers, and underemphasize the potential side effects of drugs.
The congressional probe focuses on the Lipitor ads, but is likely to examine other spots, such as actress Sally Field's endorsement of the osteoporosis drug Boniva, according to staffers for the House's Subcommittee on Oversight and Investigations.
"We are concerned that consumers might be misled by Pfizer's television ads for Lipitor, starring Dr. Jarvik," said Dingell, in a statement. "In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine."
Stupak added, "Americans with heart disease should make medical decisions based on consultations with their doctors, not on paid advertisements during a commercial break."
In a letter to Pfizer CEO Jeffrey B. Kindler, the congressmen asked for records related to the Lipitor advertising campaign, contractual arrangements with Jarvik, the veracity of the claims made by Jarvik, and his professional qualifications.
Jarvik, 61, who invented the first successful permanent artificial heart, which was implanted in a patient in 1982, founded his own company in New York City. According to New York State Department of Education records, he is not licensed to practice or prescribe medicine in New York state.
According to his company's Web site, he has a degree in engineering from New York University, and a medical degree from the University of Utah.
Jarvik declined several requests for comment on the congressional probe, and whether he is licensed to practice medicine.
The commercials are certainly successful — for every dollar spent on direct-to-consumer advertising, the median increase in sales was $2.20, according to a study of 64 drugs included in a 2006 Government Accountability Office report.
Drug manufacturers have spent billions on advertising — primarily television and magazine ads. Researchers at Toronto's York University recently found that drug manufacturers spent, in 2004, almost twice as much on marketing and promotion — $57.5 billion — as they did on research and development — $31.5 billion.
The trade group for the industry, the Pharmaceutical Research and Manufacturing Association, disputes those numbers. Pharmaceutical research companies spent more than $55.2 billion on research and development, compared to $4.8 billion on direct-to-consumer advertising last year, according to senior vice president Ken Johnson.
"America's pharmaceutical research companies currently are testing 277 new medicines to treat heart disease and stroke, as well as 92 medicines and vaccines to treat or prevent HIV/AIDS, more than 700 medicines for diseases that disproportionately affect women, and 691 medicines to help tackle diseases that disproportionately impact African-Americans," he said in a statement.
The use of celebrity endorsers such as Jarvik and football great Joe Montana, who was a pitchman for Lotrel, a drug to reduce high blood pressure, has also come under scrutiny for its potential to mislead viewers.
"But what is the evidence that [the celebrities] actually tried other medicines for treating the same problem at appropriate doses?" asked Dr. Sidney Wolf, the head of the health research group at Public Citizen. "My guess is no. For the average viewer, they would be able to get another drug that is equally effective, and equally safe, at a much lower price."
A spokesman for Pfizer issued a statement: "Pfizer takes its responsibility with regard to direct-to-consumer (DTC) advertising very seriously. Our foremost concern is that the tone and content are appropriate for the intended audiences, and that it will ultimately result in encouraging valuable patient/physician dialogue, that can lead to appropriate treatment.
"Pfizer recognizes the important role physicians play in helping patients better manage their health. Dr. Jarvik is a respected health care professional and heart expert. Dr. Jarvik, inventor of the Jarvik artificial heart, knows how imperative it is for patients to do everything they can to keep their heart working well. Furthermore, the advertising advises consumers to speak to their physicians about their heart health."