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 today 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 today, Dr. 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, Dr.
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 prior to 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 prior to their public release. He also noted that pharmaceutical companies spend
far more on research and development of new medicines than on promotion.
Surveys indicate that direct-to-consumer advertising "helps start important
doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated," he said.
Research indicates that direct marketing to consumers increases the number
of people using certain drugs, Dr. Donohue said. The greater use is not necessarily
bad, she said, but noted that critics are concerned about safety and that the prescribing of some drugs can drive up costs.
Many Medicare recipients are heavy prescription drug users, and taxpayers are footing part of the bill for the government's
Medicare drug program, known as Part D. Another concern, she said, is that the
ads may promote drugs for problems that some might consider less of a priority, such as toenail conditions or erectile dysfunction.
The heartburn drug Nexium was the top drug in direct-to-consumer advertising in 2005, with spending totaling $224 million, according to the study. Others in the top five were the sleep aid Lunesta, the cholesterol-lowering drugs Vytorin and Crestor,
the asthma medication Advair and the allergy drug Nasonex.
Other authors of the study were Marisa Cevasco, of the Harvard School
of Public Health and the Vanderbilt School of Medicine, and Dr. Meredith Rosenthal of the Harvard public health school.
First published
at PG NOW on August 15, 2007 at 11:27
pm
Joe Fahy can