1st of 2 parts
By JIM STOMMEN
MDD Contributing Writer
Michael Coppola, MD, is chief medical officer and VP of medical affairs for NovaSom (Glen Burnie, Maryland). He also serves as president of the American Sleep Apnea Association, a patient advocacy group. Of obstructive sleep apnea, he says, "It's a big area, certainly one of the largest health problems in the United States."
Coppola is board-certified in internal medicine, critical care and sleep medicine and also is an associate clinical professor at Tufts University School of Medicine (Boston). Previously, he was national medical director of Total Sleep Diagnostics, an operator of sleep labs.
MDD: You joined NovaSom as chief medical officer in April, and continue to head up the American Sleep Apnea Association. Are there more similarities than differences in the approach taken in those two positions? I guess what I'm thinking is that a big part of both is education.
Coppola: Well, absolutely, I see the two roles as being complementary. The not-for-profit organization is there to serve patients with obstructive sleep apnea, look out for their interests and try to increase public awareness about the condition and its effects on people and society. Our role here at NovaSom is the same. We obviously are a for-profit business, but our interests are aligned with those of patients. We are trying to find cost-effective, quality solutions that can help us reach the millions of undiagnosed people with sleep apnea. Because we have a very patient-centered approach, there definitely are synergies between what we are trying to do in the private sector and what we're trying to do on the public, not-for-profit side.
MDD: Obstructive sleep apnea has a huge presence in the U.S., with an astounding level of undiagnosis and treatment. Could you delve into some of the statistics?
Coppola: There are various estimates, but they're all rather large. The feeling is that there are 40 million people in the U.S. who have obstructive sleep apnea. Probably 90% of them are undiagnosed.
MDD: It's a staggering number. How do you reach those folks?
Coppola: Public awareness is key. Word of mouth is very effective: One patient telling another patient, one spouse telling another spouse about the condition. A public dialogue is important. Sleep apnea as a condition was unrecognized until the 1970s, even though we have documentation of it going back hundreds of years, even to Roman and Greek times. The reality is that because it occurred during sleep, it was under people's radar screens. If you have chest pressure or stomach discomfort, you can describe to me in detail when it happens, why it happens, what you do to aggravate it. Unfortunately you're unconscious when you have the signs of sleep apnea, so it's less easy to recognize and to describe.
We're seeing public awareness things. For example, there are a number of TV shows which we've seen on various networks now where characters openly talk about using CPAP (continuous positive airway pressure) and have incorporated the CPAP therapy into the story line. Unfortunately, most of them have been comic; nobody talks about the stroke or sudden death or atrial fibrillation that occurs when you have sleep apnea, but it's out there, being discussed in a way that didn't occur five or 10 years ago.
The Reggie White story is one that continues to come up. Here was a wonderful man, a pro athlete who died because his CPAP equipment was under the bed and he wasn't using it. Obviously, public awareness is very important.
I personally think we need the federal government to say, hey, this is a big public health need and put some serious money behind public health education on OSA. That's the direction this needs to go in.
MDD: You talked about stroke and Afib and things like that. What are some of the other co-morbidities that get involved here?
Coppola: It's a long list. I used to say that sleep apnea, barring cancer, makes everything that adult medicine physicians worry about worse. Now, cancer is added to that list, because studies have shown that patients with OSA are at increased risk for malignancies. Diabetes, high blood pressure, stroke, heart attack, Afib, gastroesophageal reflux, but the one I really want to talk about is obesity. I was taught back in the 1970s that people snored because they were overweight, but I long have felt that people were overweight because they snore. We now have compelling medical evidence to prove that obstructive sleep apnea actually causes the weight gain, that chronic sleep deprivation causes weight gain for a variety of reasons. That's something that people don't really appreciate.
MDD: What are the biggest challenges that patients and physicians face in dealing with sleep apnea?
Coppola: The biggest challenge is that the current diagnosis and treatment algorithm is very cumbersome, is very expensive, and is awkward. The paradigm up until recently has required patients to go to a sleep lab. Often, that would require a delay of weeks, even months. Patients have to sleep in a laboratory where they have difficulty falling asleep, particularly on the first night, so they don't get the proper rest and therefore the proper diagnosis. They go back to see the physician weeks or months later and he says he needs a second study.
After the second study, the time to CPAP therapy can be delayed even further, so I've seen these kinds of processes take as long as six months it's not unusual. It's very expensive, and in today's economy people can't afford to be taking time off from work when they don't absolutely have to. So our company is very focused on developing pathways that are patient-centric, are efficient and are much less costly.
The other big challenge is that there's a prejudice out there against CPAP. I've treated thousands of patients successfully with CPAP; it's a wonderful therapy.
MDD: NovaSom developed the first FDA-cleared home diagnostic system for sleep apnea, the NovaSom Home Sleep Test, and now has a second-generation AccuSom Home Sleep Test on the market. How have they contributed to more effective treatment of the disease?
Coppola: I'd like to speak to the second test, because it's the one I'm more familiar with. The AccuSom is the first of these devices approved for wireless transmission, and that's a game-changer, because we can monitor the quality of the test remotely the first night and look at it to make sure we got appropriate data, rather than getting it back in a box and finding that there's nothing on it.
So a doctor can order a test, and if there's an urgency we can overnight it. He can order a test on Monday, we can have it in the patient's home on Tuesday, the data is transmitted to us on Wednesday and we can have a report to the appropriate sleep specialist that day. No one else can do that. Even a good sleep lab may take three days to schedule the patient, and then another three or four days to generate a report; some take a week or two.
Timely diagnosis is especially important, for example, in cases where OSA is hindering a person's ability to work, such as symptomatic commercial truck drivers. Also, in instances where a patient is scheduled for upcoming surgery and is suspected of having OSA, the anesthesia community and surgeons will want this diagnostic information for pre-operative planning. Our AccuSom tele-diagnostic protocol is well-positioned to meet such needs.
(In Part 2 of this interview next week, Michael Coppola talks about his macro views on OSA, instances where lab testing is called for, the outcomes payers should be looking for and the next big thing for the sector.)
Published August 16, 2012