Consensus among experts: the unholy grail.
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Biomedical subjects
Publications and source records attributed to L Lasagna.
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Propoxyphene napsylate differs from the hydrochloride salt in several ways. It is much less soluble and bitter and poses few stability problems when capsulated or tableted with aspirin. There is some evidence in several animal species that the pattern and severity of poisoning may be different with the two salts. Equimolar doses of the two salts are probably interchangeable in the relief of pain. The role of propoxyphene in clinical medicine and the questions of propoxyphene abuse and propoxyphene-related fatalities are discussed.
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The data on adverse drug reactions (ADRs) are incomplete, unrepresentative, uncontrolled, and lacking in operational criteria for identifying ADRs. No quantitative conclusions can be drawn from the reported data in regard to morbidity, mortality, or the underlying causes of ADRs, and attempts to extrapolate the available data to the general population would be invalid and perhaps misleading. To evaluate the impact as well as the causes of ADRs, representative populations, including general hospital and ambulatory patients of all medical specialties, must be studied, and operationally defined criteria must be used to establish the presence of an ADR in a prospective study that incorporates appropriate control populations. Similar studies on the benefits of drug use are needed to provide perspective on the risk-benefit aspects of drug therapy. Until such studies are performed, estimates of the nature and scope of the ADR problem can be only guesses.
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Twenty-nine healthy young male volunteers were screened by history, physical examination, urinalysis, 24 different blood tests, and electrocardiography for admission to a Phase I drug study. The protocol submitted to, and approved by, the FDA listed the normal ranges for the local laboratories and stipulated that the test results for any volunteers accepted should all be within these ranges. During screening 46 abnormal values were found in the laboratory tests. Only 4 subjects had all their test data within "normal" range, a result that could have been anticipated simply form the number of tests performed. These findings indicate the need for deciding on realistic protocol criteria for studies involving healthy volunteers.
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A total of 137 completed questionnaires were obtained from several population samples in an attempt to assess drug knowledge, information sources, and views on drug information with particular attention to the possible role of a patient-oriented package insert. The results indicated that the study population was variably informed and could make fairly accurate assessments by this knowledge. Responders placed great importance on the doctor and pharmacist as preferred and actual drug information sources. The mass media were accorded little prominence. Great emphasis was placed on the adequate provision of information, and this appears to be a crucial function in an adequate doctor-patient relationship. The results appear to indicate a favorable climate for establishing a patient-oriented package insert that should have summarized as well as detailed information to complement the doctor and pharmacist as primary information sources.
Dr. Lasagna was unable to attend the workshop in person, and therefore delivered his remarks by videotape, in the assumed role of the newest "Secretary of Human Experimentation" at the Department of Health, Education, and Welfare addressing a public television audience. There is no difficulty in sensing the serious truths underlying the satire in his address.
Analysis of the response to a questionnaire on various aspects of drug information showed several significant trends. The importance of the physician as an information source varied directly with age and inversely with educational level of patients. The doctor's importance as a source of information was also greater for those who visited physicians' offices or clinics more and if they were on long-term treatment. Younger persons, those with higher levels of education, and those who were not in regular contact with a physician placed greater importance on non-physician sources. Persons consulting physicians regularly desired less information and knew less about drugs than those who did not regularly see a physician. These findings suggest that the educational role of the physician could be improved and should be directed particularly at the low-income, older patient. In the design of the package insert, particular attention should be given to self-prescribed medications where no other information sources will be operating.
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A scientific delegation visited the People's Republic of China for the purpose of assessing the current status of herbal pharmacology and medicine there. China is attempting to wed traditional and Western medicine so as to take advantage of the potential contributions of both. This wedding seems possible at the empiric level despite theoretical contradictions. Traditional remedies are widely prescribed, but the actual impact of such medication on disease is difficult to assess, because of the failure of the Chinese up until now to evaluate such remedies by modern clinical trial methodology. All Western drugs are readily available in China, and indeed are manufactured for export as well as for use within the country. The current chinese approach to the patient-doctor relation, and some novel ideas with regard to both medical and surgical therapy pose provocative questions for Western physicians.