The growth of sleep medicine has clearly opened the door for many practitioners to consider the possibility of direct-to-consumer (DTC) advertising. While there may indeed be some benefit from education of the public about sleep disorders and solutions for sleep problems, there are critical elements of DTC promotion in specialty medicine that must be accounted for.

BACKGROUND

DTC advertising to promote health care services is a widely debated subject. Specialists in marketing who provide advice to potential clients with regard to developing market share or promoting a specific program often can rely only on the experience of the non-health care marketplace in formulating a cohesive strategy. There is little published research on the effectiveness of DTC advertising for medical services, outside of the very well-organized processes of the pharmaceutical industry. The bulk of DTC advertising in health care tends to be focused either on the nontraditional (ie, holistic, naturopathic, etc) or on areas of medicine that are reimbursed outside of the third-party insurance system (cosmetic procedures).

The pharmaceutical industry opened the doors to DTC advertising of their products in 1997 following Food and Drug Administration (FDA) issuance of guidelines for DTC television advertising of prescription medications. Since that time, pharmaceutical promotion grew more than threefold, yet DTC advertising makes up only 14% of total promotional expenditures.1 The extent of DTC advertising has been very relevant for sleep medicine because expenditures for two products (Lunesta, Ambien CR) have risen to more than $100 million since their release in 2004 and 2005, respectively. These numbers do not take into account expenditures by Sanofi-Synthelabo in the promotion of Ambien (zolpidem) prior to the development of the extended release compound.

In 2003, the FDA held public hearings to examine the influence of DTC advertising. The results of 1999 and 2002 patient surveys were reviewed. Several key points were made at the meeting2:

  • There is no significant negative effect of DTC advertising, although areas of concern were identified;
  • DTC advertising seems to inform patients about available treatments and foster discussions between patients and physicians;
  • Patients who ask about a specific drug are likely to be prescribed that drug; patients do not comprehend the risks and benefits in DTC advertisements;
  • Further evaluation of the brief summary in print advertising is needed.

FDA surveys of more than 500 physicians suggest that advertising leads patients to ask more questions about treatment options, requires physicians to spend more time with patients reviewing drug risks and benefits, and helps educate patients about specific health concerns.3

At those hearings, more than 200 medical professors signed a petition asking the FDA to ban advertising, calling it misleading and “not educational.” Peter Lurie, deputy director of Public Citizen’s Health Research Group, wrote that “misleading advertising contributed to the estimated 140,000 serious cardiovascular events due to Vioxx (rofecoxib) alone.” The amount of money spent on promoting Vioxx DTC ($160 million in 2000) was more than was spent promoting Pepsi or Budweiser beer. Lurie suggests that this DTC advertising resulted in irrational use of Vioxx with two-thirds of patients prescribed the medication unnecessarily.4

Proponents of DTC advertising argue that “health care organizations, physicians, and patients find many of the newer drugs to be extremely valuable” and that there is “strong evidence that some of the most important pharmaceutical information, especially relevant new information, often fails to reach physicians or patients in a timely manner.”5 The response of the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry trade group, has been that “the educational value of consumer advertising is particularly important to address under-diagnosis and under-treatment of major medical conditions such as asthma, cerebral vascular disease, and hypertension.”4

In 2005, the government of New Zealand decided that “the potential benefits of direct to consumer advertising do not justify the harms” and decided to ban DTC advertising of prescription drugs.6 This followed a 2004 parliamentary review in Canada where it was concluded that “drug advertisements could endanger rather than empower consumers by minimizing risk information and exaggerating benefits.” It was felt that “this could contribute to increased or inappropriate drug consumption.”7 Decisions such as these have isolated the United States in its allowance of DTC advertising of prescription medications.

DTC advertising can benefit patients by providing appropriate education about the range of sleep disorders and possible treatment options. With the understanding that sleep disorders remain an unmet public health problem, it is almost inevitable that there will be continued growth of sleep diagnostic and treatment facilities. How then to differentiate your program from the rest of the field?

CONTRACTUAL RELATIONSHIPS

Sleep medicine services typically refers to the diagnostic testing component (polysomnography) and clinical treatment with continuous positive airway pressure (CPAP) for identified sleep apnea. These, of course, remain the most viable components of marketing in sleep in terms of potential sources of revenue. With the wide availability of third-party reimbursement for PSG services, the temptation to reach out to the community as a whole with widespread or targeted DTC marketing is strong.

Typically, the reimbursement for sleep laboratory services by third-party sources requires the existence of appropriate contractual relationships. Nothing would be more frustrating than to discover that a broad-based and well-designed advertising campaign was building up the business of a local competitor who was shrewd enough to have invested their resources in obtaining appropriate insurance contracts for that market. This can be particularly disturbing for the freestanding sleep laboratory or independent diagnostic testing facility (IDTF) that must compete for patient revenues with local hospital systems or physician practices that may have contracts based on their underlying primary goal, the provision of health care services.

The importance of insurance contracts in a market cannot be underscored. A facility can offer the most glamorous surroundings and attentive personnel, but for the vast majority of patients, the cost associated with sleep lab studies can be excessive if their own health insurance will not pay the bill. Contracts with the majority of third-party reimbursement systems in your area are essential to the financial survival of a sleep lab. Prior to any attempts at marketing your services, you must be confident in your ability to get paid for the very high labor costs associated with polysomnography.

PHYSICIAN REFERRALS

It is essential that the advertised services of the sleep lab be able to meet the needs of patients who are responding to the DTC advertising campaign. If the sleep lab is only a diagnostic center offering PSG evaluation for sleep disorders, patients with longstanding insomnia (who make up more than 50% of potential sleep disorder patients) may be frustrated by the inability of the facility to meet their needs. In that regard, direct affiliation with a physician-sleep specialist is essential in order that the targeted marketing can truly provide the “one stop shopping” that the consumer is seeking. Sleep medicine has finally established itself as a unique medical specialty. The physician who has been reading sleep studies “forever” may not be the one best suited to managing the complexity of sleep disorder cases.

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Consider what your primary goal is in developing and operating a sleep lab or sleep disorders center. For the physician-sleep specialist owner, the opportunity to develop and advertise a program that is all inclusive and focused on the full array of sleep disorders can be much easier to promote. The physician offering comprehensive assessment and treatment will be much more readily accepted by physician peers as a resource, if they understand that the range of services offered is based on appropriate training and credentials. Physicians involved in sleep medicine should be encouraged to pursue board certification from the American Board of Medical Specialties. More than anything else, this will highlight to potential referring primary care doctors the dedication of a physician to the practice of sleep medicine.

While board certification can highlight your range of experience, there are practices that can limit your scope of experience. The facility offering diagnostic services as a means of building up a durable medical equipment (DME) business for the provision and sale of PAP machines and supplies will be limited, by virtue of their focus, in the range of services they can offer. DTC advertising for sleep apnea can be effective, resulting in very specific and targeted consumer response. At the same time, the established noncompliance with CPAP therapy (between 50% and 60%, depending on outcome measures) can readily lead to consumer dissatisfaction with a facility’s inability to address their needs. If CPAP is the only treatment available, inevitably more than half of the potential consumer pool will not accept what you have to offer and be more likely to seek services elsewhere. Those facilities that are equipped only to manage the diagnosis and treatment of “simple” obstructive sleep apnea will in time define themselves in a less than positive way in their communities.

If the decision has been made to advertise or promote your program directly to the consumer, consider the need to change tactics midstream. Few of us have the resources or deep pockets of the pharmaceutical industry. Likewise, our per-item markup or profit is considerably less impressive. It is not all that difficult to understand why advertising for insomnia medications far exceeds any expenditures for nasal CPAP machines or supplies. The market for insomnia is vast (10% of the population probably experiences chronic insomnia). The concern that patients have about using sleeping pills on a nightly basis or that their physicians have about prescribing long-term hypnotics cannot be underestimated. Tailor the message of advertising to what you are capable of providing. Long-term growth and stability of any medical program will require a commitment to quality service and effective treatment. In the end, that will garner the respect of those physicians in the community who will identify you as the sleep experts.

Paul Saskin, PhD, is director of sleep medicine services for Metropolitan Pulmonary and Hospital Medicine of Lee’s Summit, Mo, and Overland Park, Kan. He has a PhD in psychology (1984) from Yeshiva University in New York. He is Board Certified in Sleep Medicine by the ABSM and credentialed in behavioral sleep medicine by the American Academy of Sleep Medicine. He has been chair of accreditation for the AASM and performed more than 100 accreditation site visits. He is a past section chair of the behavioral sleep medicine section of the AASM.

REFERENCES

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