Direct-to-consumer advertising (DTCA) describes a promotional effort by a pharmaceutical company or other provider of medical services to present information about medications or medical services to the public in the lay media1 . Manifesting as television and radio advertisements, Internet Web sites, newspaper and magazine advertisements, billboards, and direct mailings, DTCA is becoming more prevalent. In the year 2000, $2.5 billion was spent on advertisements aimed at medical consumers2 , but by 2004, it is estimated that pharmaceutical companies spent $6.5 billion on television advertising alone3 . Providers have been shown to have mixed feelings about DTCA. For example, in a national survey of 643 physicians, 73 percent felt it helped to educate patients, but 78 percent felt it encouraged patients to seek unnecessary treatments4 . Focusing on their most recent patient inquiry, 39 percent of the physicians reported prescribing a requested drug.
Hematology products that are marketed to patients include treatments for hematological malignancies (e.g., Bexxar® for non-Hodgkin lymphoma) and their consequences (e.g., Zometa® for bone disease in multiple myeloma), coagulation factors for patients with bleeding disorders (e.g., Humate-P® for von Willebrand disease), and ancillary treatments, either to support the bone marrow during chemotherapy (Neulasta®, Procrit®) or to ameliorate the side effects of chemotherapy (Emend®, Aloxi®). Patient-directed advertisements for ancillary treatments are more likely to be found in the popular press, while advertisements for treatments and coagulation factors tend to appear in direct mailings and patient-oriented magazines such as CURE and HemAware.
The Food and Drug Administration (FDA) acquired the power to regulate medical advertising with the Kefauver-Harris Act of 1962, which created the concept of "fair balance." This is the idea that an advertisement for a medication should include an evenhanded discussion of its risks and side effects, in addition to its benefits5 . At that time, and for the following two decades, most pharmaceutical advertising was directed solely at providers; in 1985, the FDA ruled that its requirements regarding "fair balance" were sufficient to protect consumers as well.1 This ruling heralded the growth of widespread print DTCA. In 1997, the FDA further specified that pharmaceutical advertisers need not provide detailed summaries of risks and side effects in broadcast advertisements, only a "major statement" of those risks6 . A rapid rise in broadcast DTCA soon followed.
A first step toward understanding how DTCA might affect the interaction between hematology patient and clinician is to be aware of the fact it might indeed affect such interactions. Moreover, clinicans must be familiar with the information provided in the advertisements to which patients are exposed. This can be accomplished by requesting that a patient bring the prompting advertisement to the next clinic visit, or, at the very least, by asking a patient exactly what his or her understanding of the medication is in terms of benefits, risks, and cost. Another solution would be for the FDA to require that pharmaceutical companies inform clinicians of the contents of new DTCA campaigns, as the companies have sometimes done in the past. For example, when Baxter decided to provide trial doses of ADVATE to hemophiliacs in 2004, they contacted hematologists beforehand and sent along a copy of their patient mailing and flyer. This way, when patients asked about the offer, the providers were aware of what their patients had actually seen.
As G.I. Joe famously used to state at the end of his safety-related public service announcements, "knowing is half the battle." The other half, in addition to being familiar with the information that pharmaceutical companies are providing to our patients, is to understand how it affects them and, subsequently, ourselves as providers. However hematologists feel about DTCA, given the size of the pharmaceutical industry and patients' demand for information, it is likely to remain a permanent feature of American medicine. As a result, we must study it carefully, so that we may understand how it affects hematology outcomes. We need to know which patients are most likely to ask for advertised medications, how many receive them after asking, and whether DTCA ultimately results in appropriate and/or inappropriate prescribing. Armed with such data, we will be able to determine how to maximize DTCA's potential for patient education while minimizing its risk of fostering misinformation and inapt prescribing.
