In the April issue of Cosmopolitan magazine, among advertisements for Estee Lauder's self-tanning lotion and the "world's most advanced bra" from Victoria's Secret, there is a full-page ad featuring a conservatively dressed woman, her arms crossed against her sweater, her glasses plopped on top of her head.
She does not look happy or sexy, as other women in the magazine do, and the reason is stripped across the page in big letters: "You're not failing your Pap test, but it might be failing you."
The ad was placed by Digene Corp., the maker of the country's only approved test for human papillomavirus, or HPV, the leading cause of cervical cancer. Since launching the test in 2003, the Gaithersburg biotech company has been trying to persuade gynecologists to use it along with the Pap smear, pointing to studies showing that combining the tests offers the clearest picture of whether women are at risk to develop cervical cancer.
But Digene has only tapped 9 percent of the 35 million HPV tests it estimates it could sell annually, a result below Wall Street's expectations. So the firm adopted a tactic that is becoming popular among profit-starved biotechs: Advertise directly to consumers and hope they will take up the case with their doctors.
Analysts say Digene's strategy will likely increase sales. Doctors are in the customer service business, they note, and many like to please their patients when they ask for new drugs or tests. But it is also a tricky move, exposing the firm to the criticism leveled against medical ads in general, and also to sharp questioning from doctors about whether the product is as useful as the company advertises.
The Digene test is inexpensive, about $20, and published data show that using it in tandem with the Pap smear increases the probability of diagnosing cervical cancer by a factor of about 37 in 10,000. Some doctors argue that the benefit is offset by the fact that the test can trigger cancer fears among the many women who carry the HPV virus at some point in their life but never develop the disease.
"Direct-to-consumer ads for all medical drugs and devices are an attempt to increase sales by making people worry that they have a medical condition that requires treatment," said Marcia Angell, former editor in chief of the New England Journal of Medicine. "It's marketing, and it creates demands that should just be between patients and their doctors."
Digene's HPV test is its lead product, and it is central to the company's success. Digene says it is encouraged that calendar year 2004 orders for the HPV test increased 55 percent from 2003, but it has nevertheless lowered revenue estimates for this fiscal year by $10 million, to $115 million to $120 million, acknowledging it needed to better market the product.
Unlike pharmaceutical companies, which last year spent $4 billion on drug advertising, biotech companies are relatively new to consumer marketing and have far less to spend. Digene's total marketing budget is about $50 million, company officials said, and the company plans to spend as much as $6 million of that on the ad campaign for the HPV test.
Digene executives say the print ads, which will appear in nine women's magazines, and companion television spots, which are already appearing in three cities, are designed to be educational. Recent studies, they say, show most women do not know HPV can cause cervical cancer. But Digene President Charles M. Fleischman does not deny his hope the ads will also spur women to ask for the test, which is now covered for 90 percent of people with insurance.