August 24, 2007

VUSM student’s research on drug advertising highlighted

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VUSM student Marisa Cevasco co-authored a paper in the New England Journal of Medicine. (photo by Dana Johnson)

VUSM student’s research on drug advertising highlighted

Marisa Cevasco, a fourth-year Vanderbilt University School of Medicine student, co-authored a study that was published last week in the New England Journal of Medicine.

The study examined recent trends in the pharmaceutical industry's use of direct-to-consumer advertising (as opposed to other forms of promotion), assessed the timing of advertising campaigns relative to the introduction of drugs and examined trends in the FDA's regulation of drug advertising during the past 10 years.

Cevasco, along with Julie Donohue, Ph.D., of the University of Pittsburgh Graduate School of Public Health, and Meredith Rosenthal, Ph.D., of Harvard's Department of Health Policy and Management, authored “A Decade of Direct-to-Consumer Advertising of Prescription Drugs.”

Cevasco took a leave of absence from VUSM last year to obtain a Master's of Public Health degree from Harvard. There she met Rosenthal and decided to pursue research on a topic she has long been interested in.

“After college I worked for awhile for a consulting firm, and some of our clients were pharmaceutical companies. One of my first assignments was to look at advertising of prescription drugs,” Cevasco said. “Ever since, it's just been something I've been interested in, particularly the way the pharmaceutical industry allocates resources to advertisement versus research and development.”

When the article was published last week, Cevasco was a little surprised at the attention she received.

“It was really exciting and made the year worthwhile,” Cevasco said. “I had never anticipated being published in the New England Journal. I think I was lucky to work with these two people interested in this topic.”

Cevasco's primary contribution to the study was statistical analysis and data collection. She reviewed regulatory letters that the Food and Drug Administration (FDA) sent to pharmaceutical companies from 1997-2006. During that time period, nearly 84 percent of the letters cited advertisements for either minimizing risks, exaggerating effectiveness, or both.

“What I found most interesting is the huge discrepancy between what the FDA is responsible for policing and what it is actually capable of policing. I think it is overwhelmed,” Cevasco said.

It has been 10 years since the FDA allowed direct-to-consumer advertising of prescription drugs on television. Advertising campaigns generally begin within one year after the FDA approves a new product. Evidence suggests that such advertising increases pharmaceutical sales, and both helps to avert underuse of medicines and leads to potential overuse, the authors wrote.

Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Meanwhile, the number of letters the FDA sent to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to 21 in 2006. This was due, in part, to regulatory changes that require a legal review before the FDA can issue letters.

“In 2002, the Secretary of Health and Human Services essentially put in another step before the FDA could issue a regulatory letter. By mandating a legal review first, there was a drop in the amount of letters they sent out. That was the interesting part to me, and something others may not be aware of,” Cevasco said.

Her early success with being published in a national peer-reviewed journal has left her feeling quite satisfied, but as she begins her fourth year of medical school, Cevasco is focused on a future in surgery.

“I love this topic of prescription drug advertising, but I don't want to necessarily pursue it academically,” she said. “It's been very satisfying. It was 10 months of work. To have this result and to have people read it and give us feedback has been really exciting.”