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Regulation v. competition: three states choose.
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Trace metals in sea scallops, Placopecten magellanicus, from Eastern United States.
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Serum immunoglobulin measurement during the first year of life and in immunoglobulin-deficiency states.
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The FDA may not regulate tobacco products as "drugs" or as "medical devices".
Professor Richard Merrill contends that the Federal Food, Drug, and Cosmetic Act does not grant the FDA regulatory authority over cigarettes and smokeless tobacco products. The fact that Congress did not expressly deny the FDA regulatory authority over tobacco cannot, Professor Merrill argues, be used to infer such authority. This inference is particularly inappropriate in the case of tobacco regulation, he maintains, because there is compelling evidence that Congress had no intention of delegating this authority to the FDA. He is unpersuaded that presidential approval legally sanctions the FDA's claim of authority by granting it a superficial political legitimacy. Finally, he reminds us of the FDA's own repeated denials of jurisdiction over tobacco products, and he recalls the numerous times that Congress passed legislation directed at tobacco without granting the FDA any role in its regulation. Professor Merrill's Essay, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising. The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety. The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit.
USE OF THE TERMAN-MERRILL ABBREVIATED SCALE ON THE 1960 STANFORD-BINET FORM L-M ON NEGRO ELEMENTARY SCHOOL CHILDREN OF THE SOUTHEASTERN UNITED STATES.
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Physical symptoms as indicators of depression and anxiety.
Psychological problems are the single most common reason for attrition from U.S. Navy basic training. A contributing factor is that, although military entrance processing station physicians assess numerous aspects of physical health, there is little rigor behind attempts to identify psychological disorders. In the present study, we highlight previous research indicating that patterns of physical health symptoms can provide a gauge of psychological dysfunction. We also report significant relationships between physical symptoms, anxiety, and depression in a sample of more than 2,000 sailors. Therefore, given the links between physical symptoms and psychological problems, it may be feasible for physicians who screen military applicants to use routinely gathered physical health information as part of an improved system to detect psychological disorders.
Durability of passive measles antibody in Jamaican children.
Measles antibody titres were determined by haemagglutination inhibition and by neutralization in 221 sets of serum collected from delivering mothers, umbilical cords, and infants when about six months of age. Radio-immunoassay was also used to measure antibody in 120 sera. Total IgG concentration was determined in the infant sera. All mothers had measles antibody and the mean titre was high. At the time of birth, measles antibody had been further concentrated in the infant. Nevertheless, many children lost protective titres before six months of age. The rate of loss was correlated with the infant's total serum IgG so that high IgG levels at six months correlated with rapid loss of measles-specific antibody. It is suggested that in homes where sanitation is poor, antibody is made to many agents at an early age. To maintain physiological balance, homeostatic mechanisms then increase the rate of catabolism of all IgG, including that passively acquired. In keeping with its stage of sanitary development, vaccination in Jamaica can profitably be given earlier than in the United States, but it must be later than in many African countries.
Factors associated with no surgery or radiation therapy for invasive cervical cancer in Black and White women.
This paper identifies the proportion of invasive cervical cancer cases that do not receive cancer-directed surgery or radiation; assesses the influence of race, stage, age, grade, nodal status, histology, and co-morbid cancer primaries on receipt of treatment; and considers reasons why cancer-directed therapy is not received. We analyzed data for 8,119 patients with invasive cervical cancer from eleven population-based tumor registries in the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute, 1992-96. Approximately 8.03% of Whites and 11.64% of Blacks did not receive surgery or radiation therapy (no therapy). The percentage of cases receiving no therapy were greatest for unstaged cases, and for cases with unknown grade or unknown lymph node status. Adjusted odds of no therapy significantly increased with distant and unstaged disease (vs local stage) and older age (vs 0-39) at diagnosis; unknown grade (vs well differentiated); or unknown lymph node (vs no lymph node) status. Black cases were more likely to be unstaged and unstaged cases are more likely to not receive therapy. Blacks were more likely than Whites not to receive surgery because it was not recommended, contraindicated due to other conditions, or refused. Of cases refusing radiation, 53.85% of Whites and 83.33% of Blacks refused surgery, and of women refusing surgery, 22.58% of Whites and 50% of Blacks refused radiation. Stage, age, grade, and lymph node status directly influence receipt of treatment. Race influences receipt of treatment indirectly through stage. Reasons why therapy was not received (eg, not recommended, refused) differ according to race and stage at diagnosis.
Development and testing of a labeled magnitude scale of perceived satiety.
Satiety ratings are often made using VAS or simple category scales. In order to establish a simple, more quantitative technique to index perceived hunger and/or fullness, research was undertaken to develop and test a labeled magnitude scale of satiety. Thirty-seven subjects rated the semantic meaning of 47 phrases describing different levels of hunger/fullness using magnitude estimation. Eleven phrases were then selected using criteria of response consistency, symmetry, bipolarity, and inclusion of the end-point anchors of 'greatest imaginable hunger (fullness)'. These phrases were placed along a vertical line scale at positions corresponding to their geometric mean magnitude estimates to create a labeled magnitude scale of satiety. This Satiety Labeled Intensity Magnitude (SLIM) scale was compared to VAS scales for sensitivity and reliability in two studies. In one image-based study, ANOVA with post-hoc tests showed the SLIM scale to have greater sensitivity and to have an average reliability coefficient of 0.90. In a second study using three different foods replicated on two consecutive weeks, reliability was found to be highest for the SLIM scale. It is concluded that the SLIM scale is a sensitive, reliable, and easy-to-use scale for measuring perceived satiety that has several advantages over other, more commonly used satiety scales.
Proceedings: Report of 1972 activities of the Steering Committee for Cooperative Teaching--APGO.
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Mitochondrial DNA sequence analysis of human skeletal remains: identification of remains from the Vietnam War.
Deoxyribonucleic acid (DNA) sequence analysis of the control region of the mitochondrial DNA (mtDNA) genome was used to identify human skeletal remains returned to the United States government by the Vietnamese government in 1984. The postmortem interval was thought to be 24 years at the time of testing, and the remains presumed to be an American service member. DNA typing methods using nuclear genomic DNA, HLA-DQ alpha and the variable number of tandem repeat (VNTR) locus D1S80, were unsuccessful using the polymerase chain reaction (PCR). Amplification of a portion of the mtDNA control region was performed, and the resulting PCR product subjected to DNA sequence analysis. The DNA sequence generated from the skeletal remains was identical to the maternal reference sequence, as well as the sequence generated from two siblings (sisters). The sequence was unique when compared to more than 650 DNA sequences found both in the literature and provided by personal communications. The individual sequence polymorphisms were present in only 23 of the more than 1300 nucleotide positions analyzed. These results support the observation that in cases where conventional DNA typing is unavailable, mtDNA sequencing can be used for human remains identification.
Pathways to hospital death among the oldest old.
Using the 1986 National Mortality Followback Survey (N = 2,090), this research examines the conditions under which the oldest old (85+ years of age) are discharged from a nursing home to enter and die in a hospital as well as the conditions under which community dwellers enter and die in a hospital. Given the need to plan for health services for this growing population and the recent policy changes in length of hospital stay, this analysis focuses on pathways leading to a hospital death. Results suggest that the factors that influence site of death are necessarily quite distinct for those who have entered the institutional long-term care system versus those who have not. Among institutionalized patients, the incidence of an acute condition appears to precipitate hospitalization, whereas among community dwellers, the presence of a social support network and the decedent's race are the only salient factors predicting hospital death. Implications are discussed.
Measuring "humanism" in medical residents.
The American Board of Internal Medicine (ABIM) has charged directors of residency programs with evaluating "humanistic attributes" in residents seeking certification. To investigate whether traditional measures of residents' performance assess humanistic attributes, 38 second- and third-year medical residents completed the Totalitarian-Authoritarian-Dogmatism (TAD) and Rokeach tests for attitudinal assessment. Five primary sources were used to measure performance. When the measures of performance and attitude were correlated, two negative correlations with "antipathy toward patients" were found: professional maturity (r = -.43, P less than .01) and compassion and concern for patients (r = -.35, P less than .04). The TAD Opinionnaire and the special performance evaluation detect "nonhumanistic dimensions" that routine faculty assessments do not. Since the new Likert scale distributed by ABIM does not differ materially from the rating form used at Baylor for 2 1/2 years, it is unlikely that "humanistic attributes" will be measured by the ABIM's new scale.
PI 3-kinase regulation of dopamine uptake.
The magnitude and duration of dopamine (DA) signaling is defined by the amount of vesicular release, DA receptor sensitivity, and the efficiency of DA clearance, which is largely determined by the DA transporter (DAT). DAT uptake capacity is determined by the number of functional transporters on the cell surface as well as by their turnover rate. Here we show that inhibition of phosphatidylinositol (PI) 3-kinase with LY294002 induces internalization of the human DAT (hDAT), thereby reducing transport capacity. Acute treatment with LY294002 reduced the maximal rate of [(3) H]DA uptake in rat striatal synaptosomes and in human embryonic kidney (HEK) 293 cells stably expressing the hDAT (hDAT cells). In addition, LY294002 caused a significant redistribution of the hDAT from the plasma membrane to the cytosol. Conversely, insulin, which activates PI 3-kinase, increased [(3)H]DA uptake and blocked the amphetamine-induced hDAT intracellular accumulation, as did transient expression of constitutively active PI 3-kinase. The LY294002-induced reduction in [(3)H]DA uptake and hDAT cell surface expression was inhibited by expression of a dominant negative mutant of dynamin I, indicating that dynamin-dependent trafficking can modulate transport capacity. These data implicate DAT trafficking in the hormonal regulation of dopaminergic signaling, and suggest that a state of chronic hypoinsulinemia, such as in diabetes, may alter synaptic DA signaling by reducing the available cell surface DATs.
A role for the polymorphism at position 247 of the beta2-glycoprotein I gene in the generation of anti-beta2-glycoprotein I antibodies in the antiphospholipid syndrome.
OBJECTIVE: To determine the frequencies at which either a valine or leucine occurs at position 247 in the beta2-glycoprotein I (beta2GPI) gene of normal individuals of the Caucasian, African American, and Asian ethnic groups and to compare these data with those in patients with the antiphospholipid syndrome (APS), with and without anti-beta2GPI antibodies. METHODS: The DNA segment containing the position-247 polymorphism was amplified by seminested polymerase chain reaction, and the polymorphism was detected by restriction endonuclease digestion. DNA samples from 370 healthy controls of different racial backgrounds were analyzed, and the results were compared with those from 149 APS patients (66 primary; 83 secondary). Allele and genotype frequencies were compared using Fisher's exact test. When significant differences were detected, pairwise comparisons were made using Fisher's exact test with a Bonferroni adjustment. RESULTS: Allele and genotype expression was significantly different (P < 0.0001 for both) among the 3 races, with the V allele and the VV genotype occurring most often among Caucasians, less among African Americans, and least among Asians. Conversely, the V allele and the VV genotype were found more frequently among Asian APS patients than among controls (P = 0.0028 and P = 0.0023, respectively). No significant differences in allele or genotype frequencies were seen in comparisons of the Caucasian or the African American patients with appropriate controls. The differences in allele and genotype frequencies seen in the Asian APS patients were restricted to the anti-beta2GPI-positive patients (P = 0.0018 and P = 0.0005, respectively). CONCLUSION: In Asian patients with APS, expression of a V at position 247, especially in the homozygous state, is significantly associated with the presence of anti-beta2GPI antibodies and, therefore, can be viewed as a major risk factor in this ethnic group (odds ratio 9.19 and 16.33, respectively).
Major histologic types of cancers of the gum and mouth, esophagus, larynx, and lung by sex and by income level.
Incidence rates by income level were computed for squamous cell carcinomas of the gum and mouth, larynx, and esophagus and for squamous cell carcinoma, small cell carcinoma, and adenocarcinoma of the lung in white males and females aged 35--64 years, with the use of data for the nine geographic areas of the Third National Cancer Survey and the 1970 U.S. census. Within sex, age, and geographic area groups, patterns of cancer incidence by income level were analyzed by use of a nonparametric statistical method. Higher rates for males than for females were found for every histologic type studied, and the ratio of male-to-female rates increased with age (especially for squamous cell carcinomas of the larynx and lung). A strong inverse relation to income level was found for all of the histologic types studied in males and for squamous cell carcinomas of the gum and mouth and esophagus and small cell carcinoma of the lung in females. These findings are discussed with reference to patterns of smoking and alcohol use by sex and social class.
Asian ethnicity as a predictor of response in patients with non-small-cell lung cancer treated with gefitinib on an expanded access program.
BACKGROUND: The primary objective of this retrospective study was to investigate the potential role of East Asian ethnicity or origin in predicting response to gefitinib in advanced-stage non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: A chart review was done of all patients treated with gefitinib at M. D. Anderson Cancer Center on the Expanded Access Program. RESULTS: There were 223 patients with advanced-stage NSCLC who were enrolled. Of these, 182 received >or= 1 dose, and 160 were evaluable for response. The partial response rate was 8.8%, and the stable disease rate was 26.3%. Median time to progression was 2.5 months, and median survival was 6.8 months. The 1- and 2-year survival rates were 35.3% and 12.4%, respectively. Partial responses were seen in 7 of 12 patients (58.3%) of East Asian origin compared with 7 of 131 patients who were white (5.3%). This difference was statistically significant when controlling for histology, smoking status, hemoglobin, and diarrhea. Never smoking and diarrhea were also independent predictors of response. CONCLUSION: For the first time, in a multivariate analysis, we observed a positive relationship between East Asian origin and response to gefitinib. These findings might help determine which patients will likely benefit from gefitinib.