By Wayne persky
Founder and President of the Microscopic Colitis Foundation
With concerns about sleep apnea and a few other sleep issues on the increase these days, continuous positive airway pressure (CPAP) therapy is on the increase. And concerns about a possible association of sleep apnea with issues such as heart failure, cardiovascular risk, hypertension, and various other health issues add a sense of urgency for those who suspect they might have sleep apnea.
Please note that CPAP therapy poses a unique problem for MC patients, and that issue hasn't been previously mentioned by clinicians, medical institutions, Internet websites, or anywhere else. Consequently, the problem is described near the end of this article. CPAP machines have been prescribed for many, many patients. But a few investigative reporters have raised questions about not only the growing popularity of this technology, but it's effectiveness, as well.
An online Medscape article describes the adventures of a journalist who was having problems getting a decent nights sleep, apparently, because he was becoming drowsy during the day. His wife told him that he snored, and he was worried that he had sleep apnea (Hancock, J. (2022, October 03).1
Hancock, J. (2022, October 03). Severe Sleep Apnea Diagnosis Panics Reporter Until He Finds a Simple, No-Cost Solution. Medscape, Retrieved from https://www.medscape.com/viewarticle/981785?ecd=wnl_infocu10_broad_broad_persoexpansion-algo_20230524&uac=95382HN&impID=5457531#vp_1
An online Medscape article describes the adventures of a journalist who was having problems getting a decent nights sleep, apparently, because he was becoming drowsy during the day. His wife told him that he snored, and he was worried that he had sleep apnea (Hancock, J. (2022, October 03).1
Hancock, J. (2022, October 03). Severe Sleep Apnea Diagnosis Panics Reporter Until He Finds a Simple, No-Cost Solution. Medscape, Retrieved from https://www.medscape.com/viewarticle/981785?ecd=wnl_infocu10_broad_broad_persoexpansion-algo_20230524&uac=95382HN&impID=5457531#vp_1
Everyone wants a piece of the pie.
As he pointed out in the article, the U. S. healthcare system apparently joins with commercial partners to define medical conditions (in this particular case, sleep apnea) so that both parties are able to generate revenue from "a multitude of pricey diagnostic studies, equipment studies, and questionable treatments"
After he contacted a sleep treatment center, the doctors gave him an at-home test, at a cost of $365. After about 2 weeks, they advised him that he had "high moderate" sleep apnea, and he needed to be using a CPAP machine. And before he could begin using the machine, he would have to spend a night at the sleep lab for an overnight test (at a cost of $1900) so that the doctors could adjust the CPAP machine for an optimal air pressure setting,
After he contacted a sleep treatment center, the doctors gave him an at-home test, at a cost of $365. After about 2 weeks, they advised him that he had "high moderate" sleep apnea, and he needed to be using a CPAP machine. And before he could begin using the machine, he would have to spend a night at the sleep lab for an overnight test (at a cost of $1900) so that the doctors could adjust the CPAP machine for an optimal air pressure setting,
The tests and equipment are covered by insurance.
The journalist had Medicare, plus a supplemental plan, so most of the procedures and devices that were recommended were (or at least would have been) covered by insurance. But as we all know, the cost of unnecessary healthcare is one of the main reasons why insurance premiums, co-pays, and deductibles increase virtually every year. The journalist had years of experience reporting on the healthcare business, so he investigated, and verified that the reasons behind the cascade of expensive testing imposed upon him involved significantly more than simply concerns about his health.
He found that the American Academy of Sleep Medicine (AASM), a nonprofit organization, defines sleep apnea and appropriate treatments. Their International Classification of Sleep Disorders is used by doctors around the world to diagnose and classify the disease.
He found that the American Academy of Sleep Medicine (AASM), a nonprofit organization, defines sleep apnea and appropriate treatments. Their International Classification of Sleep Disorders is used by doctors around the world to diagnose and classify the disease.
Here's a quote from what he found:
But behind that effort lie considerable conflicts of interest. Like so much of U.S. health care, sleep medicine turns out to be a thriving industry. AASM finances its operations in part with payments from CPAP machine manufacturers and other companies that stand to profit from expensive treatments and expansive definitions of apnea and other sleep disorders.
Zoll Itamar, which makes the at-home testing device I used, as well as implantable nerve-stimulation hardware for central sleep apnea, is a $60,000, "platinum" partner in AASM's Industry Engagement Program. So is Avadel Pharmaceuticals, which is testing a drug to treat narcolepsy, characterized by intense daytime sleepiness.
Other sponsors include the maker of an anti-insomnia drug; another company with a narcolepsy drug; Fisher & Paykel Healthcare, which makes CPAP machines and masks; and Inspire Medical Systems, maker of a heavily advertised surgical implant, costing tens of thousands of dollars, to treat apnea.
Corporate sponsors for Sleep 2022, a convention AASM put on in Charlotte, North Carolina, with other professional societies, included many of those companies, plus Philips Respironics and ResMed, two of the biggest CPAP machine makers.
In a statement, AASM spokesperson Jennifer Gibson said a conflict-of-interest policy and a non-interference pledge from industry funders protect the integrity of the academy's work. Industry donations account for about $170,000 of AASM's annual revenue of about $15 million, she said. Other revenue comes from educational materials and membership and accreditation fees.
Zoll Itamar, which makes the at-home testing device I used, as well as implantable nerve-stimulation hardware for central sleep apnea, is a $60,000, "platinum" partner in AASM's Industry Engagement Program. So is Avadel Pharmaceuticals, which is testing a drug to treat narcolepsy, characterized by intense daytime sleepiness.
Other sponsors include the maker of an anti-insomnia drug; another company with a narcolepsy drug; Fisher & Paykel Healthcare, which makes CPAP machines and masks; and Inspire Medical Systems, maker of a heavily advertised surgical implant, costing tens of thousands of dollars, to treat apnea.
Corporate sponsors for Sleep 2022, a convention AASM put on in Charlotte, North Carolina, with other professional societies, included many of those companies, plus Philips Respironics and ResMed, two of the biggest CPAP machine makers.
In a statement, AASM spokesperson Jennifer Gibson said a conflict-of-interest policy and a non-interference pledge from industry funders protect the integrity of the academy's work. Industry donations account for about $170,000 of AASM's annual revenue of about $15 million, she said. Other revenue comes from educational materials and membership and accreditation fees.
Surely, most of us don't have sleep apnea.
His investigations revealed that almost everyone experiences irregular breathing at various times during the night, especially during REM sleep, the part of our sleep pattern that involves rapid eye movement and dreams, and during those episodes, blood oxygen levels tend to fluctuate slightly. And further investigations found that published European studies have shown that the standards listed under the International Classification of Sleep Disorders would be diagnostic of sleep apnea for a high percentage of the world's general population, regardless of whether those individuals had any daytime tiredness or other sleep issues. One of the studies, conducted in the Swiss city of Lausanne, showed that approximately 50% of the local men, and 23% of the women who were 40 or older would qualify for a diagnosis of sleep apnea under those rules. Obviously, actual cases of sleep apnea are nowhere near that common.
So how did the journalist in this story end up resolving his sleep apnea?
When he carefully scrutinized the results of his home test, he noticed that he averaged 26 breathing interruptions (and blood oxygen level declines) per hour, which qualified for a "high moderate" apnea category. But he noticed that when he slept on his side, he averaged only 10 interruptions an hour. So he spent $25 to buy a pulse oximeter with a smart phone app that records breathing patterns and oxygenation, and found that when he slept on his side, he had very few breathing interruptions. So now he snores less, and wakes up refreshed, because he sleeps on his side.
Did any of the sleep specialists mention sleeping on his side?
Nope. Sleeping in an alternate position is known as "positional therapy", and not one of the specialists ever mentioned that he might be able to benefit from avoiding sleeping on his back. But the journalist also pointed out that not everyone is helped by sleeping on their side. Some patients actually do need a CPAP machine.
Evidence shows that CPAP machines don't resolve certain health problems.
Traditionally, doctors have been sending patients with obstructive sleep apnea (OSA) and other comorbidities such as cardiovascular disease (CVD), hypertension, and coronary artery disease (CAD) to sleep specialists. But a recent article published online on Medscape points out that a number of published research studies show that CPAP treatment does not improve CVD related outcomes (Holly, 2023, December 22).2
The CANPAP study
According to the article, in 2005, the CANPAP study found that CPAP treatment actually increased mortality if central apneas weren't eliminated, and CPAP didn't improve CVD related outcomes (Bradley, et al., 2005).3 The conclusions stated in the original research article are:
Although CPAP attenuated central sleep apnea, improved nocturnal oxygenation, increased the ejection fraction, lowered norepinephrine levels, and increased the distance walked in six minutes, it did not affect survival. Our data do not support the use of CPAP to extend life in patients who have central sleep apnea and heart failure.
The SERVE HF trial
The SERVE HF trialIn 2015, a randomized controlled SERVE HF trial was published showing that the use of adaptive servo ventilation (ASV) for the purpose of eliminating central apneas, or Cheyne-Stokes respirations (a specific periodic breathing pattern), didn't help, either (Cowie, et al., 2015).4 CPAP actually increased all cause and CVD-specific mortality. The conclusions stated in the original research article are:
Adaptive servo-ventilation had no significant effect on the primary end point in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea, but all-cause and cardiovascular mortality were both increased with this therapy.
Additional studies
And additional recent studies were cited by the article, including the RICCADSA study, the SAVE trial, and the ISAACC study. They all showed no CVD-related improvements with CPAP treatments. The respective conclusions for those studies were (Peker, et al., 2016; McEvoy, et al., 2016; Sánchez-de-la-Torre, et al., 2020):5, 6, 7
The RICCADSA study
Routine prescription of CPAP to patients with CAD with nonsleepy OSA did not significantly reduce long-term adverse cardiovascular outcomes in the intention-to-treat population. There was a significant reduction after adjustment for baseline comorbidities and compliance with the treatment.
The SAVE trial
Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease.
The ISAACC study
Among non-sleepy patients with ACS, the presence of OSA was not associated with an increased prevalence of cardiovascular events and treatment with CPAP did not significantly reduce this prevalence.
Does CPAP resolve hypertension?
The AASM conducted their own meta-analyses to support their guideline for recommending CPAP for patients who have comorbid hypertension. They note that CPAP was shown to yield a 24 hour blood pressure reduction of 1.5 mm Hg for systolic blood pressure, and 1.6 mm Hg for diastolic pressure. Such minimal reductions are not something that anyone would write home about.
Then there's the Philips Respironics scandal
All U. S. sales of breathing machines have been halted by Phillips. Although Philips Respironics will continue to sell breathing equipment in other parts of the world, apparently they have discontinued all sales in the U. S. A very recent article in the New York Times, for example, described a major problem with Phillips breathing machines (Jewett, 2024, January 29).8 Interestingly, according to the article, the terms of a settlement with the U. S. Food and Drug Administration (FDA) dictate that Phillips has not only had to recall millions of their ventilators and CPAP machines, but they've agreed to halt all sales in the U. S. The recall (which began in June of 2021) followed reports that the machines blew bits of foam and contaminated air (possibly containing toxic gases) into users airways.
Why did the FDA wait so long before they notified the public?
And why did it take them so long to even discover the problem, and begin to take action? Apparently, thousands of complaints had accumulated for more than a decade before Phillips even decided to notify patients of the problem, according to an online article on the ProPublica (a nonprofit investigative organization) website (Cenziper, and Sallah, 2024, January 29).9
During all this time, many thousands of vulnerable users of this defective equipment apparently developed cancer, respiratory problems, and other health issues, and hundreds died. Another article on ProPublica discussed the exchange of emails that occurred between the FDA and Phillips during those years, regarding complaints and safety claims, but the FDA waited before alerting the public (Cenziper, Sallah, and Korsh, 2024, February 09).10
During all this time, many thousands of vulnerable users of this defective equipment apparently developed cancer, respiratory problems, and other health issues, and hundreds died. Another article on ProPublica discussed the exchange of emails that occurred between the FDA and Phillips during those years, regarding complaints and safety claims, but the FDA waited before alerting the public (Cenziper, Sallah, and Korsh, 2024, February 09).10
What's the take away from all this?
The entire sleep apnea/CPAP industry seems to exude a faint hint of the odor of snake oil. Do CPAP machines benefit anyone? Of course they do, since they help to minimize the negative breathing effects of sleep apnea, and raise average oxygenation rates for such patients. Do they benefit patients who have CVD, CAD, heart failure, and comorbidities such as hypertension? Apparently not, in most cases, and the bad news is that CPAP use can increase the risk of mortality for certain heart failure patients. And the average benefit for those patients who have hypertension appears to be minimal. All this suggests that before relegating ourselves to the discomfort of using a CPAP machine, prudence dictates that we should carefully investigate whether we actually need such intervention in the first place, and if we do, we should carefully consider any alternative solutions that may be available to us.
The entire sleep apnea/CPAP industry seems to exude a faint hint of the odor of snake oil. Do CPAP machines benefit anyone? Of course they do, since they help to minimize the negative breathing effects of sleep apnea, and raise average oxygenation rates for such patients. Do they benefit patients who have CVD, CAD, heart failure, and comorbidities such as hypertension? Apparently not, in most cases, and the bad news is that CPAP use can increase the risk of mortality for certain heart failure patients. And the average benefit for those patients who have hypertension appears to be minimal. All this suggests that before relegating ourselves to the discomfort of using a CPAP machine, prudence dictates that we should carefully investigate whether we actually need such intervention in the first place, and if we do, we should carefully consider any alternative solutions that may be available to us.
Please be aware of a special caveat for MC patients.
MC patients who use CPAP machines typically encounter a unique problem. The inability to purge excess gas is a major problem for most MC patients, as an unrecognized (by the medical community) symptom of the disease (when it's active). Gas tends to build up in our digestive system, and we're unable to get rid of it, resulting in persistent bloating, a lot of unnecessary pain, and general discomfort. As Dr. Sharyl Magnuson, of the Board of Directors of the Microscopic Colitis Foundation, who has personally experienced this problem, describes, CPAP machines tend to pump excessive air into our digestive system, causing bloating and discomfort. In her case, the problem was bad enough to cause her to lose sleep.
Dr. Magnuson suggested the use of oral appliances to mitigate snoring and ordinary obstructive sleep apnea issues. For example, many dentists can fit patients with these appliances so that they move the lower jaw forward during sleep, allowing improved airflow into the lungs. For many patients, these appliances can provide almost the same effectiveness for maintaining normal oxygen levels, as a CPAP system, at a much lower cost.
Dr. Magnuson suggested the use of oral appliances to mitigate snoring and ordinary obstructive sleep apnea issues. For example, many dentists can fit patients with these appliances so that they move the lower jaw forward during sleep, allowing improved airflow into the lungs. For many patients, these appliances can provide almost the same effectiveness for maintaining normal oxygen levels, as a CPAP system, at a much lower cost.
References
1. Hancock, J. (2022, October 03). Severe Sleep Apnea Diagnosis Panics Reporter Until He Finds a Simple, No-Cost Solution. Medscape, Retrieved from https://www.medscape.com/viewarticle/981785?ecd=wnl_infocu10_broad_broad_persoexpansion-algo_20230524&uac=95382HN&impID=5457531#vp_1
2. Holly, A. B. (2023, December 22). CPAP Oversells and Underperforms. Medscape, Retrieved from https://www.medscape.com/viewarticle/999441?ecd=mkm_ret_240218_mscpmrk_neuro_sleep_etid6315272&uac=95382HN&impID=6315272
3. Bradley, T. D., Logan, A. G., Kimoff, R. J., Sériès, F., Morrison, D. Ferguson, K. . . . Floras, J. S. (2005). Continuous Positive Airway Pressure for Central Sleep Apnea and Heart Failure. The New England Journal of Medicine, retrieved from https://www.nejm.org/doi/full/10.1056/nejmoa051001#article_citing_articles
4. Cowie, M. R., Woehrle, H., Wegscheider, K., Angermann, C., d’Ortho, M-P., Erdmann, E., . . . Teschler, H. (2015). Adaptive Servo-Ventilation for Central Sleep Apnea in Systolic Heart Failure. New England Journal of Medicine, 373, pp 1095–1105. Retrieved from https://www.nejm.org/doi/full/10.1056/nejmoa1506459
5. Peker, Y., Glantz, H., Eulenburg, C., Wegscheider, K., Herlitz, J., and Thunström, E. (2016). Effect of Positive Airway Pressure on Cardiovascular Outcomes in Coronary Artery Disease Patients with Nonsleepy Obstructive Sleep Apnea. The RICCADSA Randomized Controlled Trial. American Journal of Respiratory and Critical Care Medicine, 194 (5). Retrieved from https://www.atsjournals.org/doi/full/10.1164/rccm.201601-0088OC
6. McEvoy, R. D., Antic, N. A., Heeley, E., Luo, Y., Ou, Q., Zhang, X., . . . Anderson, C. S. (2016). CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. The New England Journal of Medicine, Retrieved from https://www.nejm.org/doi/full/10.1056/nejmoa1606599
7. Sánchez-de-la-Torre, M., Sánchez-de-la-Torre, A., Bertran, S., Abad, J., Duran-Cantolla, J., Cabriada, V., Barbé, F. (2020). Effect of obstructive sleep apnoea and its treatment with continuous positive airway pressure on the prevalence of cardiovascular events in patients with acute coronary syndrome (ISAACC study): a randomised controlled trial. The Lancet, 8(4), pp 359–367. Retrieved from https://pubmed.ncbi.nlm.nih.gov/31839558/
8. Jewett, C. (2024, January 29). Philips Suspends U.S. Sales of Breathing Machines After Recall. The New York Times, Retrieved from https://www.nytimes.com/2024/01/29/health/philips-cpap-breathing-devices.html?unlocked_article_code=1.TE0.jBBm.4JzD1sqC3SGJ&bgrp=t&smid=url-share
9. Cenziper, D., and Sallah, M. D. (2024, January 29). Amid Recall Crisis, Philips Agrees to Stop Selling Sleep Apnea Machines in the United States. ProPublicia, Retrieved from https://www.propublica.org/article/philips-agrees-to-stop-selling-sleep-apnea-machines-in-us
10. Cenziper, D., Sallah, M. D., And Korsh, M. (2024, February 09). FDA Repeatedly Rejected Safety Claims Made by Philips After the CPAP Recall but Waited to Alert the Public, Emails Show, ProPublica, retrieved from https://www.propublica.org/article/fda-repeatedly-rejected-safety-claims-philips-breathing-machines-emails-show
