PITTSBURGH -- Direct-to-consumer advertising of prescription drugs shot up 330% over the past decade despite criticisms, researchers here found.
PITTSBURGH, Aug. 16 -- Direct-to-consumer advertising of prescription drugs shot up 330% over the past decade despite criticisms, researchers here found.
The increase came in the face of weakening FDA oversight, with a decline in regulatory letters related to promotional activities from about 140 to fewer than 10 during the same 10-year period, reported Julie M. Donohue, Ph.D., of the University of Pittsburgh, and colleagues in the Aug. 16 issue of the New England Journal of Medicine.
While acknowledging that the findings have important public health implications, the researchers were guarded in their appraisal of the situation.
"Although the evidence base is growing, there are few data to support an assessment of the balance of the costs and benefits of such advertising," they wrote.
Direct-to-consumer advertising debuted with an enigmatic television ad for loratadine (Claritin) in 1996. An FDA policy change the following year allowing advertising of prescription drugs.
Since then, studies have shown that the ads increase class-wide drug sales and correct an underuse of medications for chronic conditions but also lead to some overuse, the investigators noted.
To shed some light on trends in spending, the researchers gathered data from public and private sources on industry-wide and product-specific promotion expenditures.
They got data from three market-research firms, from an annual survey by the industry trade group Pharmaceutical Research and Manufacturers of America on industry-wide sales, and from government agencies, including the FDA.
Among their findings:
Direct-to-consumer advertising represented only 14% of the total promotional spending in 2005. But, that proportion has been climbing along with spending on free samples for physicians (to .4 billion from .1 billion in 1996) whereas the proportion spent on detailing physicians on the drugs and advertising in professional journals declined.
In 2005, eight of the 10 top-selling drug classes had at least one product that used direct-to-consumer advertising.
Although physicians remain the dominant marketing target, consumers have become a large secondary target for some drugs. For both proton-pump inhibitors and statins, 34% of the overall promotion spending was direct-to-consumer. For erythropoietin medications, it was 31% of the total marketing budget.
Some observers have expressed concern that direct-to-consumer advertising costs would be passed on to consumers in higher drug prices, the investigators said.
Although economic theory and other evidence suggest against a direct effect on prices, "which largely reflect perceptions of product value held by consumers, physicians, and payers," evidence on whether increased demand would lead to increased drug prices has been mixed, they noted.
Of more concern, the researchers said, is that the majority of direct-to-consumer marketing dollars are going for "predominantly new drugs used to treat chronic conditions."
Overall, 54.4% of spending was concentrated on just 20 drugs in 2005, of which 17 had direct-to-consumer campaigns that began within a year of FDA approval of the drug. These included esomeprazole (Nexium), eszopiclone (Lunesta), ezetimibe-simvastatin (Vytorin), and rosuvastatin (Crestor).
This "raises questions about the extent to which advertising increases the use of drugs with unknown safety profiles," the researchers wrote.
Bristol-Myers Squibb has voluntarily stopped direct-to-consumer advertising in the first year after FDA approval. The Pharmaceutical Research and Manufacturers of America and the Institute of Medicine have also recommended delays.
"Our findings suggest that calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices," Dr. Donahue and colleagues concluded.
Furthermore, FDA oversight to enforce advertising regulations declined in recent years, the investigators said. They also noted that FDA staffing dedicated to reviewing direct-to-consumer ads increased only slightly whereas spending-"and probably the volume of ads to review"-skyrocketed. Increased legal review as of 2002 hampered oversight as well, they said.
Thus, they pointed out that in 2002, three FDA staff members were dedicated to reviewing direct-to-consumer advertisements. In 2004, four staffers were reviewing such advertisements, even though spending on this form of advertising had increased by 45%."
Also "consistent with the hypothesis that staffing has not kept pace with the number of prescription-drug advertisements, the proportion of broadcast advertisements that underwent FDA review before airing declined from 64% in 1999 to only 32% in 2004," they wrote.