Cost Sometimes a Factor in Approval
But, once that leap is made, success is often found. Ciprodex works to treat granulation. Botox effectively treats salivary conditions. Yet, neither treatment has been put on label.
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December 2019Why not? Money, of course. “Botox is a relatively expensive drug,” Dr. Gillespie said. “A vial of it can run between $300 and $500. … The company makes so much money from the cosmetic use, there’s very little motivation to try to get it approved for medical use.”
Dr. Gillespie said that the size of the specialty of otolaryngology makes it difficult for pharmaceutical companies to justify spending time and money for federal approvals. “We deal with a variety of problems that are somewhat uncommon,” he said. “Whenever you’re dealing with diseases where there’s not [a] large [patient population], the evidence base tends to be weaker. If you’re treating hypertension or diabetes or COPD or heart disease, there are trials with thousands of people comparing medications in randomized, blinded fashion. However, when you’re dealing with salivary gland disorders where only one in 20,000 people [are affected] … it’s different.”
The cost and time of on-label usage needs to make sense to a company’s bottom line—and that is often even more true for medical devices.
Dr. Rutter said he tends to use a laparoscopic needle driver when inserting stiches in the larynx, even though the device is not approved for that. “If I’ve got a pouch in the trachea and I want to marsupialize it, there’s a forceps designed for laparoscopic work that works brilliantly for that particular problem,” he said. “Again, it’s a problem-solving exercise, and while it wasn’t designed for that particular use, it might work extremely well for doing it. And, if you’re dealing with the things that are a little unusual, no one’s going to make a tool just for you for something that is comparably rare.”
You have to have a certain body of lower-level evidence in the literature that shows the effect, [and] you have to have a certain number of experts in the field agreeing that a procedure is acceptable. —M. Boyd Gillespie, MD, MSc
Dr. Sataloff did, actually. He holds a patent on a thyroplasty implant that could help patients with glottic insufficiency or vocal fold paralysis. But the process to get it FDA approved could cost in the ballpark of $1 million. “I can talk about this because I make no money from it, because I doubt it will ever be manufactured,” he said. “It’s a better device than anything that we have available, but … the fact that it’s a better device is irrelevant. It’s unaffordable to get it approved because companies will never sell enough of them to get their money back.”