Health & Environment Subcommittee Hearing
New Developments in Medical Research:
NIH & Patient Groups
Lowell W. and Josephine Q. Berry Professor of Psychiatry, Stanford University Director, Stanford Center of Excellence for Sleep Disorders
Chair, National Commission on Sleep Disorders Research, 1990-1992
President, American Sleep Disorders Association, 1975-87
The Current Status of Sleep Disorders in America and the National Center on Sleep Disorders Research
March 26, 1998
Public Policy Recommendations to the U.S. Congress from the National Commission on Sleep Disorders Research (1990-1992) 1998 Update
William C. Dement, M.D., Ph.D., Chairman
Stanford University Center of Excellence
for the Diagnosis and Treatment of Sleep Disorders
Mr. Chairman, Honorable Members, I am extremely pleased to be here as a result of your burgeoning interest in the large, complex, costly, and nearly invisible health problems in our society caused by inadequate and unhealthy sleep. The language of the Concurrent Resolution submitted to the Congress yesterday by Representative John Dingell and co-signed by many members speaks volumes about these problems and about the crucial role our elected Representatives must play when solutions elude the business as usual approach of the agencies. I am sure I speak for the entire sleep disorders community when I underscore the great significance of this opportunity to work together to extend the many achievements of Americas great health research and health care system to the entire 24 hour day. I thank the Chairman of this esteemed Subcommittee, the Honorable Michael Bilirakis, for being invited to give testimony. I want particularly to thank my own Representative and member of this Subcommitte, the Honorable Anna Eshoo, for her outstanding leadership since we were privileged to send her to this House, and most particularly for her understanding, and her vigorous support of our crusade to bring the benefits of sleep medicine and healthy sleep to millions of Americans in need.
I am also very pleased that this opportunity to discuss the current status of sleep deprivation and sleep disorders in America follows on the heels of two outstanding events that took place yesterday. The first was the well attended press conference, organized by the Washington D.C. based National Sleep Foundation to announce the first annual National Sleep Awareness Week and to present the results of the 1998 NSF Omnibus Sleep in America Poll. The second event was the Congressional reception that took place yesterday evening. The assembled sleep specialists and other guests heard remarks by Representative John Dingell, Ranking Member of the House Commerce Committee, Representative John LaFalce, and Dr. Joseph Duffey, Director of the U.S. Information Agency.
My research, clinical, and public policy activities are briefly summarized in the accompanying "biographical sketch." In addition to being an elder statesman of sleep research, I have assumed that the purpose of your invitation was to receive from its Chairman an "update" on the recommendations of your National Commission on Sleep Disorders Research. The area I will address in my testimony is nothing less than every health issue that you have ever heard about applied to the sleeping human being. The fundamental principle of this effort should become as familiar to every citizen and health care professional as the ABCs. WE ARE NOT HEALTHY UNLESS OUR SLEEP IS HEALTHY! I repeat, WE ARE NOT HEALTHY UNLESS OUR SLEEP IS HEALTHY!
Honorable Members, I have good news and bad news.
The good news is that the National Center on Sleep Disorders Research, which the National Commission urged the Congress to create, is in place, has an outstanding full time Director, and, given its meager resources, is doing an excellent job. The National Sleep Advisory Board mandated by Congress is also in place, and there exists a National Research plan, which has been approved by NIH Director, Harold Varmus, who has already testified. The acquisition of scientific knowledge about sleep, biological rhythms, sleep deprivation and sleep disorders is accelerating. Patient groups are better organized and are beginning to understand their role in supporting the National Center and the NIH.
The surprising findings of the National Commission on Sleep Disorders Research which were greeted with some skepticism in 1992 have been solidly confirmed by additional NIH supported research published in outstanding peer reviewed scientific journals. One important example is the research which established the national prevalence of Obstructive Sleep Apnea, a potentially fatal illness in which victims stop breathing hundreds of times during their sleep. These epidemiological data were not available when the Commission was wrapping up. Accordingly, our estimate from the available 1992 databases was, of course, far below the findings reported by Dr. Terry Young and her colleagues in 1993. These investigators found that this serious, potentially fatal illness afflicts 24% of adults males (1 in 4) and 9% of adult females (1 in 11). The publication of their landmark study in the New England Journal of Medicine enabled the health care and scientific community to accept that 30 million Americans are suffering and, if untreated, often dying from Obstructive Sleep Apnea and its consequences.
Obstructive Sleep Apnea is only one sleep disorder. Numerous studies, including three National Sleep Foundation Gallup Polls, have established that 49% of all adults suffer from insomnia and 12% have trouble sleeping every night. Surveys eliciting the characteristic symptomology of Restless Legs Syndrome have suggested a prevalence of 15% of all adults.
Although the National Sleep Commission had access to the National Transportation Safety Board accident investigation reports as well as the investigations of the Rogers Commission, even minimal highway accident investigation databases were, and still are, few and far between. Several NTSB studies document that fatigue is the leading cause of heavy truck accidents. Nonetheless, the sheer magnitude of such catastrophes as the grounding of the Exxon Valdez, the near meltdown at Three Mile Island, the Bhophal catastrophe, and the explosion of the space shuttle Challenger, all caused totally or in part by sleepy people, convinced Commissioners that the consequences of inadequate sleep must be addressed in all components of society. The increasing attention to sleep in the media has primed Americans to hear the important messages about sleep to improve safety, health and the quality of life. With judicious fostering by the NIH, sleep science has progressed to the molecular biological and genetic regulatory levels for both sleep and its disorders and biological rhythms. Finally, a Sleep Academic Award program has been successfully launched by the National Center on Sleep Disorders Research, and there are currently awardees in eleven medical schools.
Summarizing the good news, never have we known more about sleep and although, as I will say, the need to educate is incredibly urgent, thanks to the National Center on Sleep Disorders Research and a number of sleep-related professional and patient volunteer societies, the educational materials that will be required are largely in place. In this regard, I would call attention to the excellent work of the National Sleep Foundation. This key organization has become a major national educational resource.
Now for the bad news. Fundamental to the mission of the National Institutes of Health (NIH) to foster health research is the solemn obligation to be absolutely certain that American citizens actually receive the benefits derived from this research. I am sorry to say that in the area of sleep deprivation and sleep disorders, knowledge transfer has largely failed.
In its report to the Congress in 1992, the National Commission described the serious problems it had identified, and made recommendations that would provide solutions if implemented by the U.S. Congress. In a nutshell, the Commission identified two gigantic, overarching problems: (1) Pervasive sleep deprivation with all its consequences for errors, accidents, disability, damage, and death. (2) An epidemic of more than forty million undiagnosed and untreated, or misdiagnosed and mistreated, chronically ill sleep disorders victims. The Commissions studies also revealed why these gigantic problems remain invisible and festering in our society. Knowledge about sleep was found to be completely absent from the educational system, and the small numbers of sleep researchers and clinicians did not constitute a critical mass that could manage an effective penetration.
The Commission reported these findings to the Congress in the strongest possible language, and I quote, Although knowledge about the prevalence, individual impact, diagnosis, and treatment of sleep disorders has advanced significantly over the past two decades, American society as a whole remains at a very low level of knowledge, and has limited understanding of the availability of treatment for these disorders. The absence of awareness is so pervasive and complete, it can be changed only by a strong, Federal initiative. Indeed, the low level of nation-wide awareness of the nature and impact of sleep disorders and sleep deprivation is a national emergency! Witnesses at our hearings asked repeatedly, How many preventable deaths are going to occur this year? Why don't we save as many lives as possible now, not years or decades from now? The Commission has also concluded that the American public has been inappropriately denied the benefits of the research knowledge its tax dollars have supported. This situation must be remedied without delay, therefore, the Commission recommends that a major public awareness / education campaign about sleep deprivation and sleep disorders be undertaken immediately by the federal government. The Commission recommends the addition of an annual appropriation of 3.25 million in new dollars to support this important public awareness and education program."
Five and a half years have elapsed since this report was submitted. If I were submitting the report today, I would not change one word of the above, except the funding request. The Commission language speaks of saving lives. It points out that many lives can be saved easily, dramatically. Honorable Members of this Subcommittee, in my very strong opinion, there is no evidence whatsoever that more than a minuscule fraction of the millions of diminished or lost lives are being saved today.
In 1992, the National Commission on Sleep Disorders Research reported to the Congress that the practice of medicine did not include the sleeping patient. In 1998, the practice of medicine still does not include the sleeping patient. How do I know this? When the National Commission finished its work, I turned my attention to primary care medical practice in the United States, and for the past six years I and my colleagues at Stanford have confirmed the Commission's findings over and over in a number of sites; and we have tried to understand why this terrible problem continues to exist and how it might be solved. As I speak, we are gathering data in two additional widely separated primary sites. In a careful perusal of every page of patients voluminous records, we are finding that the practice of medicine ends when the patient falls asleep. All our post-Commission studies add up to about five thousand patients whose records have been painstakingly scrutinized. In this mass of medical records we have yet to discover even one specific sleep disorder diagnosis. To make it more dramatic, we are talking of around 50 thousand patients a year without a single sleep disorder being recognized. I will repeat for emphasis -- the diagnosis and treatment of sleep disorders in primary care medicine today is essentially zero. I declare that the gap between the great things the sleep disorders knowledge that has already been acquired could do and what it is actually doing is the largest in history. I have included a visual representation of this gap (Figure 1).
Let me put human faces on this story:
Mr. George Haskell was referred to Dr. Richard Simon in Walla Walla, Washington, not for a sleep evaluation but in the hope that as a highly qualified internist, Dr. Simon could suggest some new approach to relieve the patients very severe congestive heart failure. Mr. Haskell was completely incapacitated. He was taking multiple medications for heart failure, blood pressure and fluid retention. Of course, Dr. Simon noted he had very severe Obstructive Sleep Apnea. He was immediately placed on BIPAP and this 65 year old man has had a miraculous improvement. He has lost about 58 lbs. of fluid, going from 265 lbs. to 207 lbs. He is off a number of medications and feels great. From dozing all the time, he is now alert, ambulatory and no longer disabled.
Mr. Tom Tebault was in severe congestive heart failure at the age of 42. He was found to have a sleep disorder when a proposal was sent to his father, the Executive Director of a small foundation, by Dr. William Dement. The father called and said your proposal fits my son to a T. I arranged for Mr. Tebault to be tested at a accredited sleep center. He stopped breathing 110 times every hour he was asleep. He had severe edema and hypertension. He has been on BIPAP for several weeks and is feeling much better and losing fluid. His shortness of breath is gone and he feels incredibly mentally alert.
The third patient is a young undergraduate at Stanford University, whose dormitory mates complained to Dr. Dement at a faculty talk session that his snoring kept people awake on the entire floor. Dr. Dement talked to the young man and elicited his clear symptomatology. He was tested and found to have severe Obstructive Sleep Apnea, evidence of cognitive impairment, sleepiness and, at the age of 20, high blood pressure. He will undergo treatment as soon as possible.
A nearby successful veterinarian and ex-mayor of a Bay Area city was going crazy with his need to move his legs and was unable to lie down in his bed at night and go to sleep. After a long period of the problem worsening, he finally reached a state of agitated walking in a near zombie-like somnolent state due to the profound sleep loss he was sustaining. He visited several doctors to no avail. His wife read about Restless Legs Syndrome in a newspaper and got him treated. He is extremely happy and sleeping well today. These patients, who have only recently been identified in 1998, were not recognized on multiple occasions by their primary care physicians.
The outstanding success of our health care system, and the acquisition of unprecedented knowledge by scientists supported by the National Institutes of Health has opened so many opportunities to improve the health of the nation, that we are almost bewildered. In recent years, there has been an everybody wants something mind set, and Congress has adopted a hands-off attitude toward the NIH.
I will contend that the problem of sleep deprivation and sleep disorders in America is qualitatively different from other disease areas. The lack of awareness is so pervasive that victims don't know what is wrong with them, and doctors don't ask. This same lack of awareness means that the usual societal health care mechanisms for the prompt transfer and dissemination of knowledge do not operate in the case of sleep disorders. There are no mechanisms in place to disseminate the messages, no large organizations, no masses of enlightened victims, no faculty positions, no way to break into the medical school curriculum. Therefore, the natural resistance to change in any component of society becomes an insurmountable barrier for correcting the gigantic problem of undiagnosed and untreated or misdiagnosed and mistreated sleep disorders, and the gigantic problem of the consequences of a sleep deprived society. To repeat the 1992 recommendation of the National Commission, the absence of awareness is so pervasive and complete, it can be changed only by a strong, Federal initiative.
To summarize, in June, 1993, Congress established the National Center on Sleep Disorders Research (NCSDR) and provided it with the mandate and the authority (Public Law 103-43) to implement the recommendations of the National Commission. It was intended by the Commission and its Congressional supporters that a very modest line item appropriation for NCSDR would be provided in the 1993 session. At this point, the work of the clinical and scientific sleep community and concerned legislators was set aside in favor of national budgetary concerns. Progress toward changing the way society deals with sleep was largely derailed, and millions of Americans were denied the benefits of the health research that was supported by their hard earned tax dollars.
SO, TOGETHER WHAT CAN WE DO?
Let me repeat the simple but fundamental principle around which all of the issues I will discuss can be organized. We are not healthy unless our sleep is healthy! With a few exceptions, most of the 80 plus specific sleep disorders give rise to symptoms and/or signs that can be elicited from the awake patient (by one of the very rare enlightened health professionals). Therefore, there is no reason on earth why primary care physicians should not be recognizing the many victims of sleep disorders in their practices.
As part of my own personal post-Commission crusade, I and an esteemed colleague, the late Dr. German Nino-Murcia, began traveling to my hometown of Walla Walla, Washington, to work directly with interested primary care physicians. Today, I am exceedingly proud to declare that Walla Walla is now the Healthy Sleep Capital of America and, indeed, of the entire world. Qualifying as a rural site, in this little town of approximately 23,000 between 1200 and 1400 victims of Obstructive Sleep Apnea have now been diagnosed and effectively treated. Perhaps more than 1000 victims of other sleep disorders, such as Restless Legs Syndrome, Narcolepsy and various insomnia disorders have also been diagnosed and treated.
I contend that with a tiny amount of resources and authority, this success can be everywhere.
It is also my contention that an effective national awareness campaign will have many positive consequences beyond the often miraculous restoration of individual patients. If we could see a 10-fold increase in clinical care, we would inevitably see a rational response of the health care system, particularly in the reimbursement area, and a call for increased research, both at the NIH, and in the private sector for the marketing of medications and treatment devices. There would also be calls for rational, science-based, evidence-based approaches to scheduling in our 24-hour world.
One example in recent years that can help us understand is AIDS. In the early 1980s, there was a mysterious failure of the immune system and the puzzling appearance of the so-called opportunistic diseases. There was great resistance to the widespread dissemination of information about this new threat to the health of America. In his autobiography, Surgeon General C. Everett Koop describes his struggle to make America aware of AIDS and the dangers of this virus. As you may recall, a letter from the Surgeon General was sent to every family in America. Im sure that this alone did not do the total job, and even today there is still a need for greater awareness, but that first huge effort to cross some critical threshold was carried out effectively. Sleep disorders have not crossed the awareness threshold. Our society has a little knowledge; the wrong knowledge; we have mythology; we have erroneous attributions, and mostly just plain ignorance.
In 1993, the authorizing Committees, the House Commerce Committee and its Health and Environment Subcommittee and the Senate Labor and Human Resources Committee, did their work. Public Law 103-43 that created the National Center on Sleep Disorders Research seemed to give it all the authority and mandates that it would need to carry out its mission. However, the appropriators were unwilling to make an exception in the face of the elimination of Center line-item budgets in the Budget Reconciliation Act of 1993. Accordingly, the National Center did not receive the first year 25 million dollars of support recommended by the National Commission.
Without a line item budget, the National Center on Sleep Disorders Research, which was given the solemn mission to carry out the National Awareness program, has had to compete from a position of weakness for financial support within the National Heart, Lung and Blood Institute. I have learned, in trying to understand the failure of this commission effort, if education dollars are placed in direct competition with research dollars at the NIH, education will lose every time.
In view of the current state of affairs, I do not hesitate to request that the U.S. Congress with the wise guidance of this Subcommittee amend Public Law 103-43 so that the National Center can carry out its mission as expeditiously as possible.
I contend that no person, no agency, no institute is 100 percent perfect. When your Commission submitted its report to the Congress, a field hearing of the Senate Appropriations Committee was called by the Honorable Mark Hatfield, Senior Senator from the State of Oregon, to consider the Commission recommendations. At that hearing, Senator Hatfield asked me how I felt about Congressional micromanagement of NIH. I paraphrase my reply. It is the duty of Congress, when the NIH has not fully complied with the Congressional will, to act, whether or not it risks the label of micromanaging the NIH. This is the natural, healthy tension between the biomedical scientific community and the legislative community.
One solution would be to make the National Center independent. However, it has had a good home in the National Heart, Lung, and Blood Institute. What I hope the Subcommittee will not do is agonize over some of the general limitations on line-item budgets, and FTEs, while thousands of Americans are suffering and dying needlessly. Currently, the National Center receives funding through the National Heart, Lung, and Blood Institute, and it is not easy to understand the total resources that are available. However, using one measure, which is the complete absence of recognition of serious sleep disorders in primary care medicine, these resources cannot be anywhere near adequate.
It would seem to me, with the budget deficit crisis at least in part, a thing of the past, that incremental funding beyond the appropriations increases could be specifically designated for the National Heart, Lung, and Blood Institute, with the extremely firm report language that it is intended solely for the use of the National Center on Sleep Disorders Research, with particular emphasis on an effective national training and education program. If it does not already possess the authority, the National Center should have the authority to contract out with organizations such as the National Sleep Foundation, the American Sleep Disorders Association, to carry out educational programs. We would suggest that the first annual budget, i.e. fiscal year 1999, should be at least 20 million dollars. Surely, this would be a small investment to begin to address the $100 billion in direct and indirect economic losses every year as a result of untreated sleep disorders and sleep deprivation.
There is a tremendous need for research training. It is likely that meritorious sleep research grants are funded at a satisfactory level, although large gaps of knowledge remain regarding the origins and epidemiology of sleep disorders. The legislation that created the national center gave it clear coordinating authority, and particularly the authority to interact with other Departments. The authorizing committee should make this coordination much stronger.
We suggest the following specific educational initiatives:
(1) Support for federal public awareness campaigns regarding the importance of good sleep hygiene, the prevalence and treatment of sleep disorders, and the consequences of sleep deprivation, sleep disorders and disturbed sleep. The rationale for this is that the majority of Americans remain unaware of the nature and impact of sleep disorders and sleep deprivation. Large-scale public awareness campaigns are needed to change behaviors or conditions that lead to family dysfunction, workplace accidents, automobile crashes, lost education and income opportunities, disability and premature death.
(2) There should be federal funding for educational programs aimed specifically at primary care practitioners to increase the likelihood of proper diagnosis and treatment of sleep disorders. The National Heart, Lung, and Blood Institute has supported a sleep disorders academic award program, and has funded, I believe, ten or fifteen faculty. There is no question that this appears to be a highly successful program and should be greatly expanded. The lack of medical school education is probably the worst problem and most in need of being rectified as soon as possible. Medical students, on average, receive less than two hours of instruction in basic sleep science in medical school. According to a 1991 NSF-Gallup poll, physicians failed to diagnose, or even identify one in three adults who suffer from insomnia. Many narcoleptics have seen as many as five physicians and suffered for years without being properly diagnosed and treated.
(3) Can there be legislation that will provide incentives for medical schools that receive federal funding to increase training in sleep and sleep disorders? There should also be an encouragement of sleep disorders training and career development opportunities to bring young investigators and practitioners into the sleep disorders field. In 1992, the National Commission on Sleep Disorders Research was unable to identify any specific faculty positions in U.S. universities designated for basic sleep research. Pre-doctoral students and post-doctoral fellows receiving specialized training in basic sleep research are basically nonexistent, even today.
(4) There should be support of educational programs aimed at researchers, accident investigators, and law enforcement officials in order to identify sleep-related transportation and workplace accidents properly. At least 8 states still do not have fatigue codes on their accident report forms for automobile crashes. State police and local officers remain untrained in detecting fatigued drivers and sleep-related crashes. There are no guidelines for how officers should respond to non-commercial drivers who are impaired by fatigue.
Its jurisdiction over the National Institutes of Health should permit this august and excellent Subcommittee to propose amendments to public law 104-36 so that in order to give the National Center on Sleep Disorders Research the power and authority it needs to carry out its mission. This mission is nothing short of saving and enhancing millions of lives in America immediately by national awareness and education, and for generations to come, by fostering research training, and strongly supporting the National Research Plan.
My final comment is that if research knowledge acquired through NIH supported investigations isnot going to be used to improve the health of our citizens, then we should stop allocating precious tax dollars to this agency.
I fervently hope our legislators will understand this conundrum and hasten to eliminated it. In 1998, sufficient visibility and credibility for sleep medicine and sleep science has been achieved so that anything less than unambiguous entrance into the educational, clinical, and scientific mainstream is unacceptable.
Mr. Chairman, Honorable Members of the Health and Environment Subcommittee, thank you for granting me this opportunity to present testimony regarding the current state of sleep disorders in America.
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