COMMITTEE ON NUTRITION

PEDIATRICS ◽  
1960 ◽  
Vol 25 (5) ◽  
pp. 896-899
Author(s):  

IMPLANTATION and feeding of various synthetic and natural estrogenic hormones especially diethylstilbestrol, to achieve improved efficiency of feed and better quality of carcass is a common practice among producers of livestock and poultry in this country. Androgenic agents have been used only experimentally to date. The preparations dosages and techniques employed are regulated by the Food and Drug Administration. Despite their requirement that no detectable residue of estrogenic hormones be present in edible tissues of treated animals offered for sale, some individuals maintain that the use of these hormones should be banned entirely because they believe that controls are inadequate to insure proper usage, and that analytic methods are not sensitive enough to detect minute quantities of hormones, whose repeated ingestion even in trace amounts might prove harmful. Fortunately, extensive data have been gathered on the physiologic effects of stilbestrol and other estrogenic agents, their therapeutic uses and toxicology. Also, the quantities of estrogenic residues in the tissues of treated animals have been determined. Greatest concern has been expressed over effects of stilbestrol on reproductive function on growth, and its possible carcinogenic properties. There is no doubt that stilbestrol can suppress ovulation in women if given in adequate amounts during the proper period of the menstrual cycle; and a relatively large dose (25 mg) may produce temporary impotence, but not sterility, in the male. These effects do not persist, however, when the dosage is discontinued, as the drug is destroyed and excreted in 3 or 4 days. Relatively little is known about the specific effects of stilbestrol on children since its therapeutic use has concentrated on adults.

2019 ◽  
Vol 6 (4) ◽  
pp. 215-220
Author(s):  
Sh. N Bortsvadze ◽  
Evgeniya A. Svidinskaya ◽  
T. A Dzhibladze ◽  
I. D Khokhlova ◽  
Yan Van

The article aims to assess the possibility of ultrasound scanning and dopplerstudy in the assessment of the condition of the ovaries and endometrial in patients after long intake of COC, predicting the restoration of reproductive function after the abolition of hormonal contraception. Material and methods. In 2018-2019, 37 women were examined after the abolition of oral contraceptives, which they took for a long period of time. At the time of the examination, all the patients stopped taking COC at least 2 months ago due to the fact that they were planning a pregnancy. UW the study was conducted on the apparat Voluson E8 Expert (General Electric), improving the quality of diagnostics used Automatic assessment of follicle condition based on ultrasonic echography (Sono AVCTM follicle) and tomographic ultrasound (TUI). Results. According to the study significant changes recorded 17 patients whose menstrual cycle did not recover within the first 6 months after the cancellation of COC. In a group of 20 patients with a regular menstrual cycle, the results of the study were within normal limits, pregnancy within 6 months occurred on their own in 8 of them. Conclusion. The possibilities of 3 dimensional reconstruction and programs for evaluating the follicular apparatus significantly improve the quality of ultrasound diagnostics, give more information about the presence of small follicles, blood flow in the ovarian tissue, the structure of the cortical apparatus substances and stroma, whichis the ability of a clinician to obtain a complete understanding of the condition of the ovaries and endometrial and predicting a good health of patients. The article may be of interest to obstetricians-gynecologists, ultrasound specialists, endocrinologists, reproductive specialists.


2020 ◽  
Vol 15 (10) ◽  
pp. 1522-1530
Author(s):  
Jennifer E. Flythe ◽  
Tandrea S. Hilliard ◽  
Kourtney Ikeler ◽  
San Keller ◽  
Debbie S. Gipson ◽  
...  

Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.


The Winners ◽  
2017 ◽  
Vol 18 (1) ◽  
pp. 43
Author(s):  
John Romanach ◽  
Walter E. Block

The aim of this research is to know what FDA was done to get pure food and drug. Was it to put all the eggs in one basket and entrust the objective to a monopolistic agency which suffers no financial losses when it errors or would the authors be better off relying on a private, competitive certification industry, the firms of which can earn profits for accurate assessments and losses for erroneous ones? Ensuring the quality of pharmaceuticals was concerned, the best and most efficient means toward that end was reliance on free enterprise. The method used was the literature review by applying what the authors knew about the difference between competition and monopoly to an arena where all too seldom was it applied. It finds that the FDA cannot eliminate risk; only deny people from taking the calculated risk in the hope of curing disease. Legislation such as the Compassionate Freedom of Choice Act has been introduced with the intention of empowering patients to make informed decisions and allow them to take drugs not approved by the FDA.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4377-4377
Author(s):  
Javier Munoz ◽  
Mohamad A. Younes ◽  
Karen Olarte-Merida ◽  
Philip Kuriakose

Abstract Abstract 4377 Background: Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired complement-mediated hemolytic disorder. Eculizumab, a monoclonal antibody designed to inhibit terminal complement activation, reduces intravascular hemolysis while leading to improvements in anemia, fatigue, and quality of life as well as reductions in blood transfusions and thrombosis. This medication was approved by the Food and Drug Administration (FDA) in March 16, 2007. The intent of our study was to assess if the number of patients screened for PNH has increased after the approval of eculizumab by the FDA. Methods: Retrospective single institution chart review over a period of 6 years from January 2004 to June 2010. Our study population comprised 174 patients screened for PNH by flow cytometry. Results: Between January 2004 and March 16, 2007 (39 months), a total of 68 cases were screened for PNH. On the other hand, between March 17, 2007 (date of FDA approval) and June 2010 (39 months), a total of 106 cases were screened for PNH with an increase in the frequency of testing by 55.8% (Figure 1). 1 out of 68 cases (1.5%) screened before March 16, 2007 were positive for PNH. 6 out of 106 cases (5.6%) screened after March 16, 2007 were positive for PNH (Table 1). 74 patients were male (42.5%) and 100 were female (57.5%). Average age at screening for PNH was 53.3 years. Screening was most commonly requested by Hematology (151 cases; 86.7%) followed by Internal medicine (5 cases), Hepatology (3 cases), Neurology (1 case) and Pulmonary (1 case). We found no information available in 13 cases regarding the location of the patient or the service that requested PNH screening. The clinical indications to screen for PNH were cytopenias (110 cases; 63.2%), thrombotic events (39 cases; 22.4%), or a combination of cytopenia plus a thrombotic event (9 cases; 5.2%). No indication for PNH screening was documented in 16 cases. Conclusion: Our hypothesis is that an approval of a new medication can increase both, the awareness of a disease among physicians, and the frequency of ordering its diagnostic tests. The number of patients screened for PNH sharply increased after the approval of eculizumab by the FDA, confirming our hypothesis. Disclosures: No relevant conflicts of interest to declare.


1998 ◽  
Vol 17 (1) ◽  
pp. 86-96 ◽  
Author(s):  
Louis A. Morris ◽  
Karen Lechter ◽  
Michael Weintraub ◽  
Debra Bowen

Drug products may be switched from precription (Rx) to over-the-counter (OTC) status if labeling can be written that ensures that the label information is comprehensible to ordinary consumers, including persons with low literacy ability, under normal conditions of purchase and use. The Food and Drug Administration has been working with sponsors to develop methods to test consumer comprehension of proposed OTC product labels. The authors discuss several conceptual and operational elements of comprehension testing, focusing on the goals, methods, appropriate target audience, and testing environment. The authors also examine areas in need of further research and debate. As more complex products are considered for OTC status, it is even more important to ensure that OTC labels are comprehensible. As understanding and the validity of methods to evaluate consumer comprehension improve, so should the quality of labels offered to consumers.


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