ShareThisBy JOE FAHY
Pittsburgh Post-Gazette
Thursday, August 16, 2007
Pharmaceutical companies are spending increasing amounts on advertising targeted to consumers, despite concerns that some drugs approved for distribution could later be linked to serious health risks.
A number of heavily promoted drugs were marketed to consumers within a year after their approval by the U.S. Food and Drug Administration, according to the study, published Thursday in the New England Journal of Medicine.
It "takes substantially longer for the safety profile of a drug to emerge," said Dr. Julie Donohue, lead study author and an assistant professor at the University of Pittsburgh Graduate School of Public Health.
The FDA monitors the safety of drugs after they reach the market, but that process has been criticized.
The drug manufacturer Merck pulled the painkiller Vioxx from the market in 2004 after studies found that it was associated with heart attacks and strokes. The FDA also came under fire recently for failing to alert the public to data suggesting that the diabetes drug Avandia may increase the risk of heart attack.
Both drugs were heavily advertised upon their release to the market. Legislation is pending in Congress that would strengthen the monitoring of drugs after their release.
In a report last year, an Institute of Medicine committee spoke in favor of a ban on drug ads targeted to consumers -- known as "direct-to-consumer" advertising -- in the first two years after a drug is approved, though it noted that a moratorium could face legal challenges. At the very least, the group noted, the ads should point out that evidence for risks and benefits is less developed than for older drugs.
In the study published Thursday, Donohue and other researchers concluded that a ban on direct-to-consumer ads for new drugs "would represent a dramatic departure from current practices."
The study examined trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotions to physicians.
It found that total promotional drug spending grew from $11.4 billion in 1996 to $29.9 billion in 2005.
The greatest share of promotional spending in 2005 was for free medication samples, followed by "detailing" -- visits by sales representatives to health professionals.
A number of academic medical centers, including the University of Pittsburgh Medical Center, have imposed, or are considering, limits on detailing or use of samples.
Direct-to-consumer advertising made up just 14 percent of total promotional expenditures in 2005. But since 1996, that spending increased by 330 percent, the authors noted.
About 85 percent of drug ads targeted to consumers are on television, Donohue said, noting the drug industry is not required to have FDA approval before running ads.
While industry officials generally are responsive to pulling ads in response to letters from the FDA, those letters tend to be sent after the ad campaign has run its course, she said.
The study suggested that the FDA's capacity to enforce advertising regulations has weakened in recent years. It noted that a Government Accountability Office report found that a legal review required before regulatory letters are issued has led to delays and a reduction in the number of letters.
The study also noted that FDA staffing dedicated to reviewing ads has remained stable even as the number of ads has grown. The share of broadcast ads that underwent FDA review before airing dropped from 64 percent in 1999 to 32 percent in 2004.
In a statement, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said the group generally supports legislation that would allow the FDA to hire additional workers to review direct-to-consumer ads before their public release. He also noted that pharmaceutical companies spend far more on research and development of new medicines than on promotion.
(Joe Fahy can be reached at jfahy(at)post-gazette.com.)
