Abstract
Thank you for giving us the opportunity to respond to a physician's concern about our recently published article, Injection Snoreplasty: How to treat snoring without all the pain and expense.” 1 We have been overwhelmed with hundreds of calls and e-mails from otolaryngologists across the country asking technical questions on how to get started with Injection Snoreplasty and providing positive feedback from their early experiences.
Indeed, the Physician's Desk Reference (PDR) does recommend sotradecol as an intravenous treatment of small uncomplicated varicose veins of the lower extremities. 2 However, as mentioned in our article, the use of sotradecol has progressed to involve several clinical entities of the head and neck including cystic hygromas, thyroid and parathyroid nodules and cysts, and glomus tumors. 1 This list did not include other published nonotolaryngic “off-label” uses such as treatment for bleeding esophageal or gastric varices, hydroceles, renal tumors, mucoid cysts, gall bladder ablation, sterilization, sarcomas, anal fissures, venous malformations, and colonic masses in almost 200 publications on Medline since 1973.
The use of off-label medications is clinically accepted in the majority of otolaryngology practices. For instance, in our practice, we commonly use specific antibiotic eye drops in the ear after ventilation tube placement in the ear, botulinum toxin laryngeal injections to treat spasmodic dysphonia, and key antibiotics to treat infections, such as chronic sinusitis not listed as indications in the PDR. Although these off-label medications are not approved by the Food and Drug Administration (FDA) for our specific uses, up-to-date clinical experience shows excellent patient results with their use.
The FDA regulations require relatively extended and exhaustive animal and human testing before adding an indication for a particular drug. In practical terms, developing a drug or device for specific use in this country can exceed $75,000,000 and consume up to 10 years. 3 Off-label uses abound in the medical literature, some becoming widespread without approval by the FDA. The ethical and legal implications of these actions are not always clear. The FDA does not regulate the practice of medicine, and, therefore, does not stop physicians from independently teaching, describing, performing, or prescribing off-label uses of drugs or devices.
Relatively high costs of radiofrequency ablation (RFA) and laser-assisted uvulopalatoplasty (LAUP) may partially result from extensive marketing and bureaucracy. The cost is passed on to the patient (and physician). It seems unlikely that pharmaceutical companies making sotradecol will pursue the costly FDA snoring indication as the sclerosing agent is very inexpensive, the patent has expired, and there may be other common sclerosing agents equally effective. Instead, we have presented compelling successful animal data at AAO scientific meetings well before embarking on Institutional Review Board-approved clinical trials. 4 Our goal is to provide the patient with a simple, inexpensive, safe, and effective technique to treat snoring.
Patients undergoing Injection Snoreplasty with sotradecol, a mild sclerosing agent, purposefully benefit from the local effects of extravasation described in the PDR. 2 The scarring and stiffening that result from submucosal injection are a product of tissue necrosis. This well-documented side effect of extravasated sotradecol is taken advantage of to stiffen the floppy palate and effectively treat palatal flutter snoring.
The safety profile of sotradecol over the decades has been exemplary. As with all medications, allergic reaction, including anaphylaxis leading to death, can conceivably occur. In our review, deaths potentially due to sotradecol were caused by injection of large amounts in a large vessel, such as injection into large bleeding esophagogastric varices in a patient with liver failure and portal hypertension. 5 In contrast, local injection of small amounts of sotradecol into the relatively avascular midline submucosal soft palate clearly fits a safer clinical scenario. Nevertheless, we do observe the patient after the procedure to help rule out an untoward reaction. 1 There have been none to date. Of note, other common snoring procedures such as RFA, LAUP, and cautery-assisted palatal stiffening operation require injection of local anesthesia into the soft palate. Untoward deaths from injected local anesthesia clearly outnumber those associated with sotradecol. 6 Patients undergoing Injection Snoreplasty receive no local anesthetic injections. Also, deaths from RFA, laser, and electrocautery technology are well-documented and far outnumber those from sotradecol.
An update on Injection Snoreplasty will be presented at the AAO meeting in September 2001. We have now treated over 100 cases and find the procedure to (still) be safe and efficacious. Thanks for your interest in Injection Snoreplasty. Please let us know if you have any further questions or concerns.