By Tom Ryan
A study released last week found that the pharmaceutical industry's direct-to-consumer advertising increased more than 300 percent in the past 10 years, while regulatory scrutiny of the ads' claims has declined.
According to its findings in the August 16 issue of the New England Journal of Medicine, the FDA sent fewer letters warning drug companies that commercials were overly minimizing risks or exaggerating the effectiveness of the drugs despite the rise in ads.
"In 2004, four [FDA] staffers were reviewing such advertisements, even though spending on this form of advertising (and probably the volume of ads to review) had increased by 45 percent, from $2.9 billion to $4.2 billion," said study author Julie M. Donohue, an assistant professor of health policy and management at the University of Pittsburgh Graduate School of Public Health.
In 2006, 21 warning letters were sent out versus 142 such letters in 1997, the study found. In addition, 64 percent of the ads broadcast on television in 1999 were reviewed by the FDA, but in 2004, that percentage had already declined to 32 percent.
The study comes amid growing calls for Congress to pass legislation tightening control over the ads. Critics say direct-to-consumer advertising drives up drug spending, encourages overuse of medications, and heightens risks, such as those that led to the withdrawal of Merck’s Vioxx arthritis drug.
The most heavily marketed drug in 2005 was Nexium ($224 million spent), followed by Lunesta ($214 million), Vytorin ($155 million), Crestor ($144 million), and Advair ($137 million).
The study’s authors said a moratorium, rather than just restrictions, on such advertising might be required, especially since advertising blitzes generally start before a drug's safety track record has been established in the marketplace.
"My view is that the advertising regulations that are on the books now are adequate. Prescription drug ads are among the most heavily regulated advertisements if you look at all other consumer products," Ms. Donohue told HealthDay News. "But the enforcement of the regulations needs to be there as well, and resources necessary for reviewing advertisements need to be adequate."
"And drug manufacturers do not have to have FDA approval of advertisements before airing them, so an ad campaign can run its course before the FDA is able to review the ads," she added.
In response to the study, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), said in a statement that direct-to-consumer advertising has been shown to play a key role in educating and empowering patients, improving patient understanding of disease and available treatments, and fostering strong relationships between patients and their health-care providers, and the study overlooked these "important contributions" to health.
"A national survey by Prevention Magazine found that 29 million patients talked to their doctor for the first time about a health condition after seeing a DTC ad," said Mr. Johnson. "The survey also found that of these patients, most discuss behavioural and lifestyle changes and more than half receive a recommendation for non-prescription or generic alternatives."
Discussion Question: Do you think more regulatory oversight is needed over the advertising content of drug ads? How do you weigh the benefits of "educating and empowering" patients through such ads versus the potential risks? Should drug companies pay for the brunt of costs around any increased monitoring?