and

practice of sleep disorders medicine has rapidly expanded in recent years and has provided tremendous assistance to many individuals suffering with sleep disorders. Unfortunately however, research into the basic mechanisms of sleep has failed to keep pace. Today there are almost no scientists studying this area and advanced techniques in molecular biology, neurochemistry, neurophysiology, neuroanatomy are not being applied to sleep research. Even more disheartening is that very few scientists are interested in devoting their work to exploring the mysteries of the sleeping brain. Understanding the basic mechanisms of sleep is critical if we are to continue to have further advances in clinical sleep disorders medicine. In an order to rectify this situation, a proposal has been developed which details the needs, objectives, and justification for the establishment of a program of Centers of Basic and Clinical Sleep Research. The ASDA recommends that such a program be established within NIH.

One program which has been established and which is currently providing advancements in our understanding of the regulation of the heart and lungs during sleep is a program of Specialized Centers of Research in Cardiopulmonary Disorders of Sleep. This program is located within the National Heart, Lung and Blood Institute. Through the SCOR program physicians and researchers utilize a multi-disciplinary approach to examine disorders such as sleep apnea and SIDS. Another program within NHLBI is a sleep apnea intervention study which would examine whether sleep apnea imparts significant morbidity and mortality and whether it can be reversed. The Association is grateful for the support that this Committee has provided for these program and encourages continued funding.

Finally, as previously mentioned, the National Commission on Sleep Disorders Research will soon be making their recommendations to Congress. One of the preliminary findings of the Commission is that sleep disorders and inadequate sleep are a pervasive problem in this society and that à contributing factor in this problem is a lack of information and understanding about sleep. In order to begin to immediately address this problem, the ASDA recommends the initiation of a nationwide public education campaign to provide available information about sleep and sleep disorders. Such a campaign, directed toward the general public, industry representatives, and health professionals, would be useful in helping to eliminate the personal suffering and financial loss associated with inadequate sleep and untreated sleep disorders. Thank you for the opportunity to present the views of the American Sleep Disorders Association. I would be pleased to respond to any questions.

STATEMENT OF JOE PISCOPO, TREASURER, AMERICAN NARCOLEPSY ASSOCIATION, INC.

Senator HARKIN. Mr. Piscopo, welcome back to the subcommittee. It is good to see you again.

Mr. PISCOPO. Thank you, Senator Harkin. I am the current treasurer and a director of the American Narcolepsy Association. I am also a member and the current vice chairman of the National Commission on Sleep Disorders Research. I am here today to urge your support of increased Federal funding for narcolepsy research.

The American Narcolepsy Association represents more than 4,000 persons with narcolepsy in the United States. I have suffered from narcolepsy since age 14. Narcolepsy is a sleep disorder characterized by excessive daytime sleepiness and sleep attacks without warning and without regard to the amount or quality of the prior night's sleep. Sleep may occur at inappropriate times such as on the job or at school or while driving, reading, or eating. Other symptoms of narcolepsy are cataplexy, a temporary loss of muscle control triggered by ordinary emotions, vivid hallucinations, and sleep paralysis.

It is estimated that nearly 400,000 Americans suffer from narcolepsy, making it more prevalent than multiple sclerosis or hemophilia. Narcolepsy typically appears during the early teenage years. It is a lifelong illness with no known cure or preventive treatment. The sleepiness of narcolepsy can be treated with dangerous stimulant drugs which have undesirable side effects; but most

narcoleptics are undiagnosed and untreated with little hope for a successful, happy life.

Mr. Chairman, narcolepsy research is primarily conducted at the National Institute on Neurological Disorders and Stroke, the NINDS. Despite this subcommittee's strong support with specific language encouraging greater narcolepsy research at NINDS in each of the past 3 years, total narcolepsy research has not increased from the fiscal year 1986 level of only $1.27 million. Last year only nine grants were awarded, a total of $1.25 million. Only 3 of the grants, a total of $173,000, were awarded for clinical research on human narcolepsy.

With all due respect, Mr. Chairman, that is not good enough. The ANA recommends that the committee specifically provide that $2.5 million of the authorized funding for NINDS be designated for narcolepsy research in the coming year. Such an authorization would enable the recently expressed interest in narcolepsy research by NINDS to hopefully result in an actual increase in the number and amount of grants awarded for narcolepsy.

The National Commission on Sleep Disorders Research was established by Congress to develop a long-range national plan_for basic and clinical sleep research and sleep disorders medicine. The recommendations of the commission are expected to be completed and reported to Congress in September of this year. Our early findings from public hearings across the United States indicate that there are significant needs for a stronger Federal focus on accountability for research on narcolepsy and other sleep disorders, for increased public awareness about sleep disorders and for better physician education and training programs.

PREPARED STATEMENT

The commission's work has a potential impact on the lives of narcolepsy patients in a dramatic way. At the same time, it is possible to save many millions spent on health care today and avoid the many thousands of lives lost and the billions spent for property damages each year as a result of accidents which could be prevented. We ask the committee to enthusiastically support the findings of the National Commission on Sleep Disorders Research by promptly implementing and adequately funding its recommendations.

Thank you, Mr. Chairman, for the opportunity to speak today. [The statement follows:]

STATEMENT OF JOSEPH A. PISCOPO

Mr. Chairman, my name is Joe Piscopo, I am the treasurer and a director of the American Narcolepsy Association. I am also a current member of the National Commission on Sleep Disorders Research. I am here today to urge your support of increased Federal funding for narcolepsy research.

The American Narcolepsy Association represents more than 4,000 persons with narcolepsy in the United States. I have suffered from narcolepsy since age 14. Narcolepsy is a sleep disorder characterized by daytime sleep attacks, without regard to the amount of prior night sleep. Sleep may occur at inappropriate times, such as while working, driving, eating, or in school. Other symptoms of narcolepsy are muscle weakness, vivid hallucinations and sleep paralysis.

It is estimated that nearly 400,000 Americans suffer from narcolepsy, making it more prevalent than multiple sclerosis or hemophilia. Narcolepsy typically appears during the early teenage years. It is a life-long illness, with no known cure or pre

ventive treatment. The sleepiness of narcolepsy can be treated with dangerous stimulant drugs, which have undesirable side effects. But most narcoleptics are undiagnosed and untreated, with little hope for a successful, happy life.

Mr. Chairman, narcolepsy research is primarily conducted at the National Institute on Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH). despite this subcommittee's support and emphasis on greater narcolepsy research over the past three years, total narcolepsy research at the NINDS had not increased from the fiscal year 1986 level of only $1.27 million.

Last year, only 9 grants were awarded, a total of just $1.25 million. Only 3 of the grants, a total of $173,000, was awarded for clinical research on human narcolepsy.

With all due respect, Mr. Chairman, that's just not good enough! the American Narcolepsy Association recommends that the committee specifically provide that $2.5 million of the authorized funding for the NINDS and the NIMH be designated for narcolepsy research in the coming fiscal year. Such an authorization would enable the recently expressed interest in narcolepsy research by the NINDS and the NIMH to result in an actual increase in the grants awarded for narcolepsy.

The national commission on sleep disorders research was established by Congress to develop a long range national plan for basic and clinical sleep research and sleep disorders medicine. The recommendations of the commission are expected to be completed and reported to Congress in September, 1991. Our early findings from public hearings across the United States indicate significant needs for greater research funding for narcolepsy and other sleep disorders, increased public awareness, and better physician training programs. The commission's work has the potential to impact the quality of life of narcolepsy patients in a dramatic way. We ask the committee to support the findings of the National Commission on Sleep Disorders Research, by promptly implementing and funding its recommendations.

Thank you Mr. Chairman, for the opportunity to appear before the subcommittee today. I'd be happy to respond to any questions you may have.

Senator HARKIN. Thank you very much, Mr. Piscopo. Let me just ask, first of all you have mentioned the funding for narcolepsy research has been stable since 1986.

Mr. PISCOPO. Yes, sir.

Senator HARKIN. This subcommittee included in its report last year a suggestion that NINDS increase the research, and I can assure you that we are going to follow up on this.

Mr. PISCOPO. I appreciate that.

Senator HARKIN. How much would be required to fund the recommendations of the National Commission on Sleep Disorders Research for fiscal year 1992?

Mr. PISCOPO. The recommendations are not yet finalized. I am the commissioner. The commission has not completed the final recommendations, and it is obligated to do so in the final report. Those numbers will be included. There will be none for this current fiscal year, I believe, because the report will be in the next fiscal year.

Senator HARKIN. OK, thank you both very much for being here. I appreciate your testimony. Good to see you again, and we will continue our efforts in this area.

Mr. PISCOPO. Thank you, Senator Harkin.

Dr. CZEISLER. Senator, there was an article in the New York Times yesterday describing some recent work that we had done with the astronauts.

Senator HARKIN. I am afraid I did not read it. Let me see it. I would be interested in reading that.

STATEMENT OF ALVIN V. BLOCK, PRESIDENT, ESA, INC., BEDFORD, MA Senator HARKIN. Our last witness today is Al Block, president of ESA, Inc. Thank you very much.

Mr. Block, welcome to the subcommittee. Please proceed.

Mr. BLOCK. OK, thank you, Mr. Chairman. I am Alvin Block, president of ESA of Bedford, MA. I would like to discuss the application of our technology of pattern matching to help problems, particularly nerve degenerative disorders.

Last year I reported that we were rapidly making progress in adapting this technology to the diagnosis of three of the most debilitating diseases in our society, Alzheimer's, Huntington's, and Parkinson's. I asked Congress to recommend that the NIH fund a program that would lead to the development of a diagnostic data base using this technology. You have done this. Thank you.

Massachusetts General Hospital and ESA submitted a proposal to the NIA to develop this data base. We have received positive feedback from NIA, who would like to fund it. In studying Huntington's disease, we have found specific relationships between low level marker compounds that are not present in normal patients. I predict that within a year using easily obtainable samples, we will be able to identify patients with Huntington's disease with near certainty.

One advantage of this technique is that by identifying the biochemical abnormalities of a disorder, a research can determine the neurochemical deficiencies, and this can lead to approaches for treatment and cure. Our colleagues at the MGH have begun animal studies which initially show possible success in the treatment of Huntington's.

Today's story sounds ideal. A small company makes good by dint of brains and hard work, and I wish this were the whole story, but it is not. Europeans and Japanese are buying our instruments at rates that exceed our original expectations. Japan has for a long time been one of our major customers. Now they are purchasing our most sophisticated instrumentation. The story in Europe is the

same.

We are concerned that the United States is losing its position of scientific superiority to foreign competition in the use and application of this revolutionary technology. American researchers need more funds to acquire sophisticated instrumentation. We feel that a goal should be a data base with which to rescreen all of the Alzheimer's patients to provide a solid foundation of data for developing possible pharmaceutical treatment.

What would be the financial impact if we are right? There are 4 million people who are presently diagnosed with Alzheimer's. They cost the United States $90 billion per year for their health care. Probably as many as 40 percent of these people do not in fact have Alzheimer's, for which there is little useful treatment. They have other diseases for which treatment is available at relatively little cost.

PREPARED STATEMENT

We estimate $35 to $40 billion could be diverted to other programs or used to reduce the budget deficit, and, more importantly, some of the 2 million Alzheimer's victims now consigned to hopeless, custodial care might get a chance to live again.

Thank you.

[The statement follows:]

i

STATEMENT OF ALVIN V. BLOCK

Mr. Chairman, I am Alvin V. Block, president of ESA, Incorporated, of Bedford, Massachusetts. Thank you very much for the opportunity to appear once again before you and the Committee to describe the progress that we are making in applying our unique technology to health problems, particularly neurodegenerative disorders. Last year I told you about the start of ESA in an abandoned warehouse in Cambridge where we developed a practical method for detecting lead levels in blood. We have continued to improve on the basic technology and its applications to health and environmental areas. This technology has evolved to a new level which we call Pattern Recognition.

To date, we have been awarded 56 patents on various embodiments of the technology.

The technology as implemented is a system for electrochemical detection and analysis of unique markers in disorder states. A year ago, I reported to you that we were rapidly making progress in adapting this technology to the diagnosis of three of the most debilitating diseases in our society: Alzheimer's, Huntington's and Parkinson's. I specifically asked the Congress to recommend that the National Institutes of Health (NIH) fund a program that would lead to the development of a diagnostic database utilizing this technology.

You have done this and I thank you. With the Massachusetts General Hospital (MGH), ESA has submitted a joint proposal to the National Institute on Aging to develop a database for a differential diagnosis of Alzheimer's, Parkinson's, Huntington's and normals. We have received positive feedback from the National Institute on Aging who would like to fund this proposal. The investigators from Massachusetts General Hospital and the University of California feel that it will require approximately $10 million to complete this study. Because NIH has limited funds, we are proposing a limited approach which will analyze samples of cerebrospinal fluid (CSF) and nasal wipes only and not blood and urine.

Under this concept, we and our scientific colleagues and collaborators, funded by the National Institute on Aging, will be examining in detail the many chemical components found in these biological samples. We have found, in the case of Huntington's disease, specific relationships between low level marker compounds that are not present in normal patients. These relationships can be used in the diagnosis and understanding of the mechanisms of Huntington's. These patterns of chemicals can be easily identified with our instrument and the accompanying computer software. I predict that within a year we will be able to take blood, urine or some other even more easily obtainable samples and identify those patients with Huntington's disease with near certainty.

One of the advantages to this technology is that, by identifying the biochemical abnormalities of a disorder, a researcher can better ascertain neurochemical deficiencies. This will lead to approaches for treatment and cure. Our colleagues at the Massachusetts General Hospital have begun animal studies which, initially, show possible success in the treatment for Huntington's disease.

Furthermore, this technology is already being applied to develop diagnostic tests for a number of other diseases. We are hoping to achieve the same success with these as with Huntington's. In fact, we and others who have become familiar with this blend of electrochemical detector mapping technology and Pattern Recognition believe that within the next five years we will be able to diagnose many diseases very effectively from a small sample of blood, fluid from the central nervous system, or even from a simple nasal swab.

This same technique may be used to effectively provide early detection of various forms of cancer and emergency diagnosis of myocardial infarction.

Another area where this technology has great potential utility is in chemical quality control, particularly as it applies to food, such as in detecting adulteration of beverages. While this type of application isn't as important as disease detection in human terms, of course, it still has great economic significance to several geographic areas of our country.

The story I bring you today sounds ideal-a small company makes good by dint of brains and hard work. I wish that this were the story, but it isn't.

Europeans and Japanese are buying our instruments at rates that exceed our expectations. Japan has for a long time been a major customer for some of our less sophisticated instruments. Now they are purchasing our most sophisticated instrumentation using this unique technology and it is being used in a variety of basic and applied research areas. The story in Italy, the United Kingdom and Austria is the same. We know how these instruments are being used in a general sense. But we don't completely know the extent of the basic research or applications to which these foreign customers are applying these highly sophisticated instruments. We are