Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-04-30
2002-03-05
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S489000
Reexamination Certificate
active
06352712
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to dietary supplements and medical foods for treating fatigue-related syndromes. The compositions of the present invention include rosemary.
BACKGROUND OF THE INVENTION
In 1948, the World Health Organization defined health as not only the absence of disease, but also the presence of physical, mental, and social well-being. (Constitution of the World Health Organization. In: World Health Organization, Handbook of Basic Documents. 5th ed. Geneva: Palais des Nations, 3-20 (1952)). The status of a patient's physical, mental, and social functioning is often referred to in the literature as quality-of-life and is used as a measure of health outcome. In the past 25 years, there has been a nearly exponential increase in the evaluation of quality-of-life as a technique of clinical research as a component of determining clinical benefit from an intervention protocol. For example, in 1973, only five articles listed quality-of-life as a key word in the Medline database, whereas in the subsequent four years there were successively 195,273,490, and 1,252 such articles. (Testa MA and Simonson DC,
N Eng J Med.
334:835-840 (1996). In 1998, approximately 3,724 articles listed quality-of-life as a key word. Thus, the health outcome, or quality-of-life, associated with a clinical intervention has been recognized as an important tool in measuring effectiveness and costs of medical care. (Wilson IB and Cleary PD., JAMA., 273:59-65 (1995)).
Extensive research has resulted in the development of instruments that measure health outcome using quality-of-life tools that follow academically well-established and statistically validated psychometric principles. (Ware J E Jr.,
J Chronic Dis.,
40:473-480 (1987); Spilker B., Quality of Life and Pharmacoeconomics in Clinical Trials, 2nd ed. Philadelphia, Pa: Lippincott-Raven Co; 1995.) One such tool is the SF-36 (Short form-36), which has been widely used in clinical trials and in clinical practice to assess health outcome. (Clancy CM and Eisenberg J M,
Science,
282:245-246 (1998)). The SF-36 was derived from the Medical Outcomes Study, which involved 11,336 patients from 523 different clinical sites. (Ware J E, Sherbourne C D, Davies A R. Developing and testing the MOS 20-item short-form health survey. In: Stewart AL and Ware J E, eds., Measuring functioning and well-being: The Medical Outcomes Study approach. Durham, N.C.: University Press, 277-290 (1992); Ware J E. SF-36 Health Survey: manual and interpretation guide. Boston, Mass.: Nimrod Press; 2:1-3:22 (1993)). The validity and reliability of the SF-36 has been proven in several studies in which researchers tested internal consistency, within subject reliability, and differentiation between patient populations. (McHorney CA, et al.,
Medical Care,
31:247-263 (1993); McHorney CA, et al.,
Medical Care,
30:S253-S265 (1992); Jenkinson C, et al.,
Br Med J.,
306:1436-1440 (1993); Brazier J E, et al.,
Br Med J.
305:160-164 (1992)). The SF-36 has been shown to predict the course of depression during a two-year study, and to be lower overall in patients who experience chronic health disorders. (Wells K B, et al.,
Archives General Psychiatry,
49:788-794 (1992); Schlenk E A, et al.,
Quality of Life Res.,
7:57-65 (1998)).
The SF-36 is a 36-item questionnaire that assesses eight dimensions of health outcome: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Results from the questionnaire can be reported as a relative number on a scale of 0 to 100, in which 100 is the highest or most functional and 0 is the most compromised for that category of functioning. A summary of the meaning of high and low scores for each category is shown-in Table 1.
TABLE 1
Description of Very High and Very Low Scores for the Eight
Categories of the MOS SF-36 Questionnaire.
Interpretation of a Low
Interpretation of a High
SF-36 Category
Score
Score
Physical
Limited in performing all
Performs all types of
Functioning
physical activities including
physical activities including
(PF)
bathing or dressing due to
the most vigorous without
health
limitations due to health
Role-Physical
Problems with work or
No problems with work or
(RP)
other daily activities
other daily activities as a
as a result
result of physical health
of physical health
Bodily Pain
Very severe and extremely
No pain or limitations due
(BP)
limiting pain
to pain
General Health
Evaluates personal health as
Evaluates personal health as
(GH)
poor and believes it is
excellent
likely to get worse
Vitality
Feels tired and worn out
Feels full of pep and energy
(VT)
all of the time
all of the time
Social
Extreme and frequent
Performs normal social
Functioning
interference with normal
activities without
(SF)
social activities due to
interference due to physical
physical or emotional
or emotional problems
problems
Role-Emotional
Problems with work or
No problems with work or
(RE)
other daily activities as
other daily activities as a
a result of emotional
result of emotional
problems
problems
Mental Health
Feelings of nervousness and
Feels peaceful, happy, and
(MH)
depression all of the time
calm all of the time
The latter half of the twentieth century has been characterized by an increasing prevalence of chronic disorders. Indeed, seven of the ten leading causes of death in the USA are chronic in nature, accounting for 72% of the deaths from all causes. (National Center for Health Statistics. Health, United States, 1995. Hyattsville, Md.: Public Health Service, 1995.) Chronic disorders such as rheumatic disorders, chronic pain, and fatigue contribute to the 6% of the population that is impaired to some extent in the conduct of major life activities such as work, school, and self-care. (US Department of Health and Human Services, Public Health Service. Healthy People 2000: National Health Promotion and Disease Prevention Objectives. Hyattsville, Md.: Public Health Service; 1991.) Health care use also appears to be substantial for patients with chronic conditions. For example, patients with chronic fatigue syndrome (CFS), fibromyalgia (FM), and multiple chemical sensitivities (MCS) have been shown to visit medical care facilities on average 22.1, 39.7, and 23.3 times per year, respectively. (Buchwald D, Garrity D.,
Arch Intern Med.,
154:2049-2053 (1994)).
In chronic conditions such as rheumatic disorders, fatigue and energy-deficit disorders, and chronic pain, biological and physiological factors have an inconsistent relationship to symptoms. (Wilson IB, Cleary PD.,
JAMA,
273:59-65 (1995)). Therefore, they are difficult to measure by laboratory values. In fact, in clinical practice, anywhere from 30% to 80% of patients who see a physician may have conditions for which no physiological or organic cause is found after routine investigation. (Wilson IB and Cleary P D,
JAMA,
273:59-65 (1995)).
For example, the term fibromyalgia (FM) refers to an illness whose major characteristics are widespread chronic pain and the physical finding of pain in specifically located tender points. (Wolfe F, et al., The American College of Rheumatology 1990 criteria for the classification of fibromyalgia.
Arthritis Rheumatology,
33:160-172 (1990)). Fibromyalgia patients also commonly report morning stiffness, fatigue, and sleep disturbances. A patient presenting with fibromyalgia sometimes reports peripheral athralgias, which can be confused with rheumatoid arthritis. (Goldenberg D L.,
Current Opinions in Rheumatology,
5:199-208 (1993)). However, fibromyalgia is commonly accepted in the field as pain not associated with inflammation nor joint dysfunction, whereas athralgias are considered inflammatory joint disorders.
Another example of a chronic condition is “chronic fatigue syndrome” (CFS). Clinical diagnosis of CFS requires that the patient show evidence of fatigue lasting beyond 6 months, as well as having eight or more of the following minor symptoms: fever, sore throat, myalgia, muscle weakness (which may be exacerbated by exercise), athralgia,
Bland Jeffrey S.
Darland Gary K.
Irving Tracey A.
Liska DeAnn J.
Lukaczer Daniel O.
Knobbe Martens Olson & Bear LLP
McQueeney P.
Page Thurman K.
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