This story missed half of our marks, despite including some very good information about costs and despite talking to a range of independent sources. If the story had spent a little less time echoing the device makers’ enthusiastic descriptions of the product and the breathless — no pun intended — descriptions by sleep apnea sufferers and more time drilling down into the evidence behind this device, it could have been a very well rounded piece.
Sleep apnea affects about 5% of the population according to most estimates — and counter to the lead. The current treatment involves a rather cumbersome device. A simpler solution would, no doubt, be welcome to people with sleep apnea. But smaller doesn’t necessarily mean better. Stories like these need to make that distinction clear.
The story offered one of the most thorough discussions of costs we have seen in a description of an emerging device. It provides a price for a 30-day supply of the patches and for a 10-day trial pack. It also points out, helpfully, that “Unlike C.P.A.P., Provent is not covered by Medicare and most major insurers, though some doctors say they expect that will change in the near future.”
The story references “a large study of 250 apnea sufferers published in the medical journal Sleep and subsidized by Ventus,” the maker of the Provent patch. But it fails to quantify the benefits found in this study. Instead it says “those who used Provent devices over a three-month period saw their apnea episodes fall sharply, compared with people who were given a sham, or placebo, device. A follow-up study tracked people over the course of a year and had similar results.”
Let’s put this in perspective: One of the patients profiled in the story awakened 42 times a hour prior to using the Provent device. Subjects who used the Provent device in the published study reduced awakenings by about 50%. So someone like Mr. Bleck would be expected to reduce awakenings to ONLY 21 per hour.
There is no mention of harms in this story.
Both the Provent device and the sham device were very similar in design and use. Both were adhesive “bandaids” place over the nostrils and both restricted exhalation through the nose (although the sham device did so less). Although the device was shown to have no side effects in the published study, about 16% of those using the Provent device stopped doing so by month 3 (as compared to 13.6% who used the sham device). That means about 1 out of 6 patients using the nasal “bandaids” stopped doing so relatively soon. The reasons for stopping were not provided but we can assume that discomfort was at least one of the reasons.
The story does mention that the main study used to support any claims that Provent works was funded by the maker of the product. But it gives the reader so little information about the study that it is hard to judge how much faith to put in it. For example, the device appears to have been tested against a placebo, but there is no sense of how Provent performs against the standard treatment, C.P.A.P.
There seems to have been some disease mongering in the first sentence. Most estimates of sleep apnea in the published literature puts the condition at somewhere between 15 million and 18 million. We could find no reference in PubMed to 28 million Americans suffering from the disorder. This would mean that nearly 1 out every 10 people have sleep apnea. The story also uses marketing language, calling the Provent patch, a “new weapon in the battle against sleep apnea,” and saying that “many patients who struggled with C.P.A.P. call it a godsend.”
The story quotes from a range of sources, and we give it high marks for that. We are a little troubled that one of the most outspoken boosters of this product is Dr. Joseph Golish, who works for another medical device company, CleveMed. He was also quoted raving about Provent in The Plain Dealer. A mention of his device company work would have been good context.
The story does compare the Provent patch to the standard treatment, known as continuous positive airway pressure, but it does not explain that there are indeed other approaches including exercise and weight loss, oral appliances and surgery. One additional line in the story could have addressed this.
The story makes it clear that this device is becoming more widely prescribed but is not necessarily found everywhere.
The story begins by contrasting this new treatment with the existing treatment. It says “For decades, the standard treatment has been “continuous positive airway pressure.” A mask worn at night pushes air into the nasal passages, enabling easier breathing. C.P.A.P. reduces and in some cases completely prevents episodes of apnea. But the mask is like something from a bad science fiction movie: big, bulky and obtrusive. Many patients simply refuse to wear it or rip it off while asleep. Studies show that about half of all people prescribed C.P.A.P. machines stop using them in one to three weeks.” The story makes the claim that the Provent patch is “far less intrusive than the traditional C.P.A.P. machine.” The claim of novelty is not backed up by the evidence presented in the story or by any published clinical trial. As we noted above about one out of every six people using the Provent in the study stopped using it after 3 months.
The story does not rely on a press release.