FDA Guidance on Sinusitis and Its Potential Impact on Treatment

Trends reflected in the current literature reveal a true step toward better understanding of CRS, as well as an effort to raise the bar as it pertains to the quality of research being dedicated to all aspects of this disease. And although it is encouraging to witness the diversity of interest in CRS that has emerged over the past decade, real improvement at the point of patient service remains relatively unchanged. Patients continue to suffer and practitioners continue to struggle with a lack of reasonably consistent management options.

Where Does That Leave the Physician and Patient?

One of the real-world issues that influences physicians’ ability to treat CRS is the lack of medications that are indicated by the FDA for the treatment of CRS (or chronic sinusitis). Health care providers are forced to choose from a number of available nonindicated medications that are selected based on currently available information via a wide range of sources. Given the state of the current literature regarding this disease, it is not surprising that dogma and anecdote frequently assume a significant role in the selection of treatment choices. Having long used this approach, some consistencies emerge when specialty-specific groups are queried, but variances remain large. In a questionnaire survey mailed to the nonresident members of the American Rhinologic Society, medical management of CRS was addressed.6 This group of specialists indicated that the mainstay of therapy was the combination of long-term antibiotic therapy and intranasal corticosteroid sprays. On the other hand, nasal saline, oral corticosteroids, and allergy immunotherapy were employed less consistently by respondents. It is reasonable to think that even more variance may exist among less specialized physicians.

This practice of varied use of medications based on an individual physician’s experience is currently the only approach available and most certainly reflects the standard of care, but it is also laden with a number of potential pitfalls and is not consistent with current principles of evidence-based medicine. At the very basis of the problem at hand is the lack of basic efficacy and safety data as they relate to medical therapies for CRS. Inconsistent and unpredictable treatment outcomes resulting in patient frustration, frequent call-backs, and doctor shopping by patients are all too often encountered in patients with CRS. These problems are compounded by the expense of a nonsystematic approach to medical care. Failed therapy results in direct treatment-related costs, as well as the indirect costs associated with loss of productivity. To make matters worse, in some cases medications used to treat CRS are not covered by third-party payers because of their non-FDA indicated status.