Lack Of Approval Research Articles

Diary of Fire by Elías Miguel Muñoz

Reviewed by: Diary of Fire by Elías Miguel Muñoz Isabel Álvarez-Borland Muñoz, Elías Miguel. Diary of Fire. New Jersey: Tincture Lethe, 2016. Pp. 333. ISBN 978-1-59021-580-7. In Elías Miguel Muñoz latest book, Diary of Fire (2016), the narrator’s moving reflections structure a fictional diary that explores sexuality, childhood trauma, and family relationships. At the center of the memoir is the narrator’s deep desire to understand himself. This self-search however is deeply intertwined by the abuse the narrator suffered as a child and by his broken relationship with his father. Muñoz was born in Cuba in 1954, and emigrated with his parents to the United States when he was fourteen years old. Like many of his Cuban American writer peers who came over during adolescence, his writing shares a sensibility based on the division or rupture with a childhood that took place in a different language and in another geography. A sense of unresolved contradictions colors most of Muñoz’s previous works, a body of work that spans several genres: novel, poetry and literary criticism. With greater urgency, and now from the perspective of a writer in his early sixties, Muñoz’s Diary of Fire (2016) returns to the issues of self-understanding and to the individual’s need and right for living an authentic life. Diary of Fire fluctuates between past and present and between Cuba and the United States keeping the trauma of displacement and discovery of sexuality as important centers of the memoir. In so doing its speaks of the narrator, Camilo Macías, breaking away from his father’s homophobia, the scars of child abuse, and Camilo’s coming to terms with his sexual identity. Several chapters titled “Cuba in Silence” return to Camilo Macías and the traumatic events of his Cuban childhood. It is precisely the reader’s experience of witnessing both the present and the past of the narrative that adds significance to what is being read and renders poignancy as well as pathos to the events related. The prominent scar in this fictional diary is the abuse Camilo suffered in Cuba as a seven year-old child by a family friend, Eduardo, a thirty year-old man who lived near his home and who had won the confidence of his unsuspecting parents. It is those scenes that deal with molestation that seem to torture the narrator as he fights to erase them from his mind: “Memories brought anguish; they made him confront the horrors of what was done to him. Yet he kept reliving them, writing about them. “I write because I remember the pain,” he said. “And it’s still with me” (118). In fact, it is the frustrating memory of the sexual abuse that remains deep in Camilo’s unconscious and often reappears as the narrator tries to grapple and analyze what [End Page 498] exactly happened to him as a child. Camilo describes sordid instances of this abuse in a distanced tone that at times contrasts vividly with the horror of what is being related. Camilo’s child voice also recalls with grief the homophobia of his father and his verbal and sometimes physical abuse for suspecting the sexual preferences of his son. As a child, his spirit was broken by a father’s brutality and lack of approval. The family fits the Cuban stereotype, the father exudes machismo, the mother is pictured as understanding but unable to stop the father’s behavior. As someone betrayed by his country, the father is deeply hurt by historical circumstance and refuses to have any positive interactions with those around him. Sad scenes are narrated about how the father forbids Camilo to develop his artistic interests and how the child was forbidden to have friends who were not macho enough for his father. When the family decides to leave the island of Cuba as exiles, a time of loneliness and resentment against his father grows inside the child’s heart. The past lurks close as the Cuban memories of sexual prejudice and physical violence keep returning to Camilo’s mind. The present of the narrative relates...

Flibanserin for hypoactive sexual desire disorder: place in therapy.

The pathophysiology, diagnosis and treatment of female sexual interest in pre- and post-menopausal women present a complex arena for patients and physicians to navigate. Flibanserin was the first pharmacologic treatment, approved by the United States Food and Drug Administration in August 2015, for hypoactive sexual desire disorder (HSDD) in premenopausal women. Side effects, contraindications and lack of approval in postmenopausal women are all limitations, as are issues surrounding patient and physician knowledge and access. Testosterone, buspirone, sildenafil, bupropion, bremelanotide, as well as herbal medications (Herbal vX or Tribulus terrestris) have demonstrated some clinical benefit in women with sexual dysfunction disorders however, trials have significant design, dosing or generalizability limitations. Nonpharmaceutical cognitive behavioral therapy, mindfulness meditation, pelvic floor therapy, and clitoral stimulators are also interventions women may pursue. This manuscript will explore the clinical data regarding these therapeutic modalities so as to bring attention to this issue of female HSDD, to offer an overview of current research, and to incite providers to initiate discussion among themselves and their patients.

Is There a Future for Chemoprevention of Prostate Cancer?

The outcome of the Selenium and Vitamin E Cancer Prevention Trial, demonstrating harm and no preventive activity of selenomethionine and α-tocopherol for prostate cancer, and the lack of approval by the FDA for the use of 5α-reductase inhibitors to prevent prostate cancer have cast doubt about the future of chemoprevention of prostate cancer. This article attempts to critically assess whether the notion that chemoprevention of prostate cancer has no future is warranted. Risk of prostate cancer is modifiable and chemoprevention of prostate cancer, particularly fatal/lethal cancer, is both needed and possible. However, the approach to prostate cancer-chemopreventive agent development has not followed a rational and systematic process. To make progress, the following steps are necessary: (i) identification of intermediate biomarkers predictive of fatal/lethal disease; (ii) development of a rational approach to identification of candidate agents, including high-throughput screening and generation of information on mechanism and biology of candidate agents and potential molecular targets; and (iii) systematic evaluation of the predictive value of preclinical models, phase II trials, and intermediate biomarkers for the outcome of phase III trials. New phase III trials should be based on adequate preclinical and phase II studies. Cancer Prev Res; 9(8); 642-7. ©2016 AACR.

Skin Necrosis Following Adipocitolitic Solution Injections

Injectable fat-reduction techniques emerged in the world literature in 2001, when Patricia Rittes, a dermatologist in Sao Paulo, Brazil, reported reduction of infraorbital fat after direct, transcutaneous injection of phosphatidylcholine (PC) combined with sodium deoxycholate (DC) solution.1 Despite lack of approval by any regulatory body, PC/DC combinations have been used off-label by healthcare practitioners to reduce subcutaneous fat in selected patients.2,3 In Europe, the only drug with CE marking (approval) for the reduction of localized fat is Aqualyx (Marllor International; San Giovanni in Marignano, Italy).4 Currently, it is approved in approximately 50 countries. Aqualyx is a DC-based solution with a lactose-based delivery system, formulated to control and enhance the action of external ultrasound waves for the microcavitation of adipose tissue.5 It does not contain PC. Aqualyx was designed for the medical treatment (reduction) of localized adipose tissue5 and is sold exclusively to physicians trained in intralipotherapy, the injection technique for its insertion.6 The product has been in clinical use since 2009 for the nonsurgical reduction of localized adiposity, lipohypertrophy, subcutaneous lipohyperplasia, and “buffalo hump”.6-8 Aqualyx is an aqueous microgelatinous solution comprised of the following: polymer of 3:6-anhydro-L-galactose and D-galactose; buffer systems; 3-alpha-12alpha-dihydroxy-5-beta-24-oico cholanic acid sodium salt; and saline solution.7,8 The solution appears similar in composition to DC, but it is considered a medical device—not a drug. A claim regarding this matter has been submitted to the Italian Ministry of the Health.8 Aqualyx is marketed as a 2-step product: immediately following injection (step 1), it is recommended that external ultrasonography be performed (step 2).5 However, …

Immunization and socioeconomic status of children 12-59 months attending a specialist hospital, Gusau, Nigeria

Introduction: Immunization remains an important public health intervention. Morbidity and mortality caused by vaccine-preventable diseases are still high in developing countries. We aimed to assess the immunization coverage among children 12-59 months old attending our pediatric outpatient clinic and determined the impact of socioeconomic status and parental education level on the utilization of immunization services. Materials and Methods: This was a cross-sectional study in under-fives attending the pediatric outpatient clinic over a 1-month period. A questionnaire was used to collect information on demography, immunization, parental occupation and level of education, and reasons for not completing immunization. Results: Of the 223 children enrolled, 121 (54.3%) were male and 102 (45.7%) were female. One hundred three (46.2%) were fully immunized, while 120 (53.8%) were not. More males were fully immunized; however, this was not significant (χ2 = 0.606, P = 0.436). The majority (65%) of the patients belonged to the lower socioeconomic class; socioeconomic status was associated with immunization status (χ2 =10.460, P = 0.005). The level of education of both parents was also significantly associated with immunization status [father (χ2 = 14.134, P = 0.000), mother (χ2 = 21.507, P = 0.000)]. The main reasons for not completing immunization were ignorance of when to go back for the next dose, lack of approval by the father, the child being ill, and the mother traveling with the child. Conclusion: A large proportion of children was not fully immunized. Poor educational and socioeconomic statuses of the parents were some of the major reasons identified. Intensive community sensitization and awareness programs should include both religious and traditional leaders so as to reverse this situation.

Practice Patterns of Allergen Immunotherapy in Korea: Where Are We?

Practice Patterns of Allergen Immunotherapy in Korea: Where Are We?

A flagrant case of scientific fraud

Scientific fraud is a reality, and although its frequency is not known, it is suspected to be far more common than actually detected. Recently, a case has been identified that has had a great impact, and which has required the withdrawal of 88 articles published by Dr. Joachim Blodt in international journals (Annex 1). The triggering event was a series of denouncing letters, following the publication of an article (Joachim Boldt, Stephan Suttner, Christian Brosch, Andreas Lehmann, Kerstin Rohm, Andinet Mengistu. Anesthesia & Analgesia 2009;109:1752--62), reporting the suspected fraudulent generation of data. This led to an investigation and to the request for proof from Dr. Boldt, who failed to reply, and was thus unable to refute the accusations. The investigation was in turn extended to other publications in which he appeared as first signing author or as co-author, and resulted in the withdrawal of 88 articles----all in the setting of Intensive Care Medicine and Anesthesia. The fundamental reason for the denouncement made by Steven L. Shafer, Editor-in-Chief of Anesthesia & Analgesia, was the lack of approval by the Ethics Committee----in this case the Landesarztekammer Rheinland-Pfalz----and the absence of randomization and of the signing of informed consent on the part of the patients. These publications were considered non-ethical, since their reference to the Ethics Committee had been falsified. At present a com-

Focus

Focus

Global Health in General Surgery Residency: A National Survey

Interest in global health during postgraduate training is increasing across disciplines. There are limited data from surgery residency programs on their attitudes and scope of activities in this area. This study aims to understand how global health education fits into postgraduate surgical training in the US. In 2007 to 2008, we conducted a nationwide survey of program directors at all 253 US general surgery residencies using a Web-based questionnaire modified from a previously published survey. The goals of global health activities, type of activity (ie, clinical versus research), and challenges to establishing these programs were analyzed. Seventy-three programs responded to the survey (29%). Of the respondents, 23 (33%) offered educational activities in global health and 86% (n = 18) of these offered clinical rotations abroad. The primary goals of these activities were to prepare residents for a career in global health and to improve resident recruitment. The greatest barriers to establishing these activities were time constraints for faculty and residents, lack of approval from the Accreditation Council for Graduate Medical Education and Residency Review Committee, and funding concerns. Lack of interest at the institution level was listed by only 5% of program directors. Of the 47 programs not offering such activities, 57% (n = 27) were interested in establishing them. Few general surgery residency programs currently offer clinical or other educational opportunities in global health. Most residencies that responded to our survey are interested in such activities but face many barriers, including time constraints, Residency Review Committee restrictions, and funding.

Current management of metastatic melanoma

Metastatic melanoma and current treatments are reviewed. Despite the many advances in cancer treatment that have occurred over the last several decades, the prognosis for patients with advanced melanoma remains poor. The 5-year survival rate for patients with distant metastases is less than 10%. For these patients, surgery and radiation therapy are primarily used to palliate symptoms. Most patients with advanced melanoma receive systemic therapy. Single-agent cytotoxic chemotherapy with dacarbazine is the standard of care in community practice, although the response rate is generally low and few patients attain complete remission. Temozolomide is an orally active congener of dacarbazine that is at least as effective as dacarbazine when used as single-agent cytotoxic therapy. Low-dose extended temozolomide regimens may provide greater antitumor efficacy. Combinations of dacarbazine or temozolomide with other cytotoxic therapies have not markedly improved patient survival. Newer agents (e.g., lomeguatrib and decitabine) have been developed to overcome mechanisms of drug resistance. Biotherapy using high-dose interleukin-2 has been shown to induce durable responses lasting 5 years or more in some patients, although the overall response rate is not substantially better than that with dacarbazine. Interferon alpha is also used for the treatment of metastatic melanoma, despite lack of approval by the FDA for this indication. Some evidence suggests that combining chemotherapy and biotherapy agents (biochemotherapy) increases the rate of treatment response but does not significantly extend overall survival. New strategies are needed to improve treatment response rates and duration of overall survival in patients with metastatic melanoma.

Perception and practice of sublingual immunotherapy among practicing allergists

Currently, little information is available regarding who is using sublingual immunotherapy (SLIT) in the United States, what product they may be using, how they are dosing that product, and what perceived effect it may be having on patients. To gather information regarding the perception and use of SLIT among practicing allergists in the United States. On behalf of the American College of Allergy, Asthma and Immunology (ACAAI) Immunotherapy and Diagnostics Committee, an electronic survey was sent to all practicing allergists of the ACAAI in March 2007. The survey response rate was 25.7% (828/3,217) in which 92.5% of the respondents (766/828) practiced in the United States. For 61.7% (471/763) the most cited reason for not using SLIT was lack of approval by the Food and Drug Administration (FDA). If SLIT were an FDA-approved form of immunotherapy, 65.7% would use it to treat allergic rhinitis, 45.5% would use SLIT to treat patients younger than 5 years, and 40.9% would use it to treat moderate to severe asthma. A total of 5.9% (45/766) of US allergists reported using SLIT. Most perceived SLIT to be as effective (44.7%) or more effective (10.5%) than subcutaneous immunotherapy (SCIT). Most allergists who used SLIT (65.9%) had it reimbursed by patients paying out of pocket. The most commonly used extract (79.1%) was a commercially available extract used for SCIT. Some practitioners (53.5%) required their patients to administer doses of SLIT in their office, but 81.8% only required that this be done with the first dose. Practitioners gave epinephrine injectors to 41.5% of their patients receiving SLIT. Although only 5.9% of US allergists reported using SLIT, most of the 828 surveyed (766 US allergists) viewed SLIT as safe and effective and would consider using SLIT if it were an FDA-approved therapy.

Parturients Expect Safe and Clean Regional Anesthesia

Parturients Expect Safe and Clean Regional Anesthesia

Women's perceptions and social barriers determine compliance to cervical screening: Results from a population based study in India

Background: Success of cervical screening initiatives depends on high participation of the target population, which in turn is determined by the women's perceptions, health orientation and other socio-cultural issues. The present study identifies the immediate social and cultural barriers that prevent women to attend cervical screening facilities. Methods: Women non-compliant to a community-based cervical screening program were identified. From them 500 were randomly selected for interview using a structured questionnaire that was designed on the basis of feedbacks received from several focused group discussions. Questionnaire listed 24 possible reasons for non-compliance. The women were asked to select the most pertinent reason(s) for her non-attendance or to reveal if they had any reason other than the listed ones. Results: A total of 469 non-compliant women were interviewed. They had significantly lower literacy rate compared to the compliant women (OR = 2.25; 95% CI: 1.23–4.13). Nearly half of the interviewed women responded that they themselves opted to stay away from the program. Most common reasons cited for non-attendance in this group were reluctance to go for medical test in the absence of any symptoms and apprehension to have a test that detects cancer. Second major group of responders comprised of women who were willing, yet could not attend due to various hurdles. Most common hurdles were inability to leave household chores, pre-occupation with family problems and lack of approval from husbands. Conclusions: Modification of health behavior through education and social empowerment of women are essential for a population based cervical screening program to succeed in India.

From the FDA

DRUG labeling is of vital importance in guiding the safe and effective use of approved drugs. Drug labels represent the most visible expression of months or years of scientific review by physicians and scientists at the U.S. Food and Drug Administration (FDA), and they are also fundamental to the purpose and mission of the FDA. Creation of the FDA dates to the 1906 passage of the Food and Drugs Act, which prohibited the manufacture and interstate shipment of adulterated and misbranded foods and drugs.† A 1937 disaster, in which more than 100 people died after ingestion of Elixir Sulfanilamide, precipitated the Federal Food, Drug, and Cosmetic Act of 1938, which, for the first time in U.S. history, required demonstration of safety before marketing new drugs. Elixir Sulfanilamide contained diethylene glycol and had never been tested for safety. In 1960, a marketing application for the drug thalidomide was submitted to the FDA. Withstanding enormous pressure from the applicant, FDA reviewers, including Frances Kelsey, M.D., Ph.D., a medical officer at the Center for Drug Evaluation and Research at the FDA (Washington D.C.),‡ determined that inadequate data were available to support the safety of the drug product despite its already widespread use throughout the rest of the world. The application was not approved. After thousands of children in 46 countries were born with deformities as a consequence of thalidomide use, leaving the United States relatively unscathed, a political movement for tighter drug controls in the United States gained popular support. The Drug Amendments of 1962 were the first to require demonstration of effectiveness before marketing, recognizing that the assessment of safety must also consider benefit. Since 1962, more than a thousand prescription drugs have had their labeling changed or have been taken off the market to reflect the scientific evidence (or lack thereof) documenting their safety and/or effectiveness.§ Section 505 of the Federal Food, Drug, and Cosmetic Act (21 USC 355) currently specifies that approved drugs must be safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Current regulations stipulate the following labeling requirements:

Survey of the use of organic nitrates for the treatment of chronic congestive heart failure in the united states

A survey of members of the Heart Failure Society of America revealed that despite their lack of approval by the United States Food and Drug Administration, nitrates are widely used in patients with chronic congestive heart failure (CHF). Most members reported using nitrates in patients with ischemic (90%) and nonischemic (81%) causes of chronic CHF, especially those with symptomatic CHF (43% reported using nitrates in >50% of their patients with ischemic and 25% with nonischemic causes). Ninety-six percent reported using nitrates to reduce symptoms, 74% for hemodynamic improvement, 65% for better exercise tolerance, and only 14% for left ventricular reversed remodeling. Nitrates were always combined with hydralazine in 25% of patients and occasionally combined with hydralazine in 67%.

HIPAA???Clinical and Ethical Considerations for Nurses

Congress enacted the Health Insurance Portability and Accountability Act (HIPAA) to protect patients' basic rights to privacy and their control over the disclosure of their personal health information. Advances in and the more widespread use of communication technology were increasing the public's concerns over the ease with which their health information could be transmitted, how protected that information was during such transmissions, and their lack of approval for the use of that information by known and unknown third parties. This article, the first of two papers focusing on HIPAA, discusses HIPAA from the clinical perspective and focuses primarily on the HIPAA Privacy Rule. Under what circumstances can a covered entity disclose protected health information? What are the ethical issues inherent in HIPAA? What does HIPAA require of covered entities? What are the implications of HIPAA for professional nurses? The goal of HIPAA is to ensure the protection of confidential health information through having appropriate security systems to guard against unintentional disclosure of that information.

Selegiline for Alzheimer's disease.

Alzheimer's disease is the most common cause of dementia in older people accounting for some 60% of cases with late-onset cognitive deterioration. It is now thought that several neurotransmitter dysfunctions are involved from an early stage in the pathogenesis of Alzheimer's disease-associated cognitive decline. The efficacy of selegiline for symptoms of Alzheimer's disease remains controversial and is reflected by its low rate of prescription and the lack of approval by several regulatory authorities in Europe and elsewhere. Reasons for this uncertainty involve the modest overall effects observed in some trials, the lack of benefit observed in several trials, the use of cross-over designs which harbour methodological problems in a disease like dementia and the difficulty in interpreting results from trials when a variety of measurement scales are used to assess outcomes. The objective of this review is to assess whether or not selegiline improves the well-being of patients with Alzheimer's disease. The Cochrane Dementia and Cognitive Impairment Group Register of Clinical Trials, was searched using the terms 'selegiline', 'l-deprenyl', "eldepryl" and "monamine oxidase inhibitor-B". MEDLINE, PsycLIT and EMBASE electronic databases were searched with the above terms in addition to using the group strategy (see group details) to limit the searches to randomised controlled trials. All unconfounded, double-blind, randomised controlled trials in which treatment with selegiline was administered for more than a day and compared to placebo in patients with dementia. Data were extracted independently by the reviewers (JSB & LF), pooled where appropriate and possible, and the weighted or standardised mean differences (95%CI) estimated. Where possible, intention-to-treat data were used but usually the meta analyses were restricted to completers' data (data on people who completed the study). There are 15 included trials. All trials examined the cognitive effects of selegiline, and in addition, 12 trials examined the behavioural and mood effects. The results of 8 trials suggested some beneficial effect of selegiline in the treatment of cognitive deficits and in 3 trials in the treatment of behaviour and mood. The meta-analysis revealed benefits on memory function as evidenced by improvement in the memory tests from several cognitive tests. Pooling the data for all cognitive tests suggested significant benefits in those subjects treated with selegiline as compared to controls. There were benefits in mood and behaviour as demonstrated by measurements on the Brief Psychiatric Rating Scale and the Dementia Mood Assessment Scale. The global rating scales showed no effect of selegiline. Unfortunately, the evidence using standardised global cognitive scales was extremely limited, for both the MMSE and ADAS-cog. A variety of adverse effects were recorded, but very few patients left a trial as a direct result of the intervention. Although the evidence for a beneficial effect of selegiline on patients with Alzheimer's disease is promising there is not yet enough evidence to recommend its use routinely in practice. The individual patient data review will yield further evidence on the effects of selegiline compared to control as would additional studies evaluating the use of selegiline for the endpoints of standardised cognitive scales, clinician impression of global change, dependency and caregiver quality of life.

Antiparasitic Agents

In recent years, introduction of new and more effective agents has improved the overall therapy for parasitic infections. This field, however, is still plagued by numerous problems, including the development of resistance to antimicrobial agents (especially with malaria), unavailability of agents in the United States or lack of approval by the Food and Drug Administration, and major toxicities or lack of experience in pregnant women and children, which limits use in these groups of patients. Widespread resistance of Plasmodium falciparum to chloroquine and other agents has complicated the treatment and prophylaxis of this type of malaria. A combination of quinine and Fansidar is usually effective oral therapy for falciparum malaria; quinidine may be administered if intravenous therapy is needed. Mefloquine, which is currently recommended for prophylaxis against chloroquine-resistant P. falciparum, is also effective for single-dose oral treatment, although this regimen has not yet been approved by the Food and Drug Administration. Metronidazole has been widely used for treatment of gastroenteritis due to Entamoeba histolytica and Giardia lamblia (not approved by the Food and Drug Administration for the latter) and is considered safe and effective. A new macrolide, azithromycin, has been reported to be effective for cryptosporidiosis in experimental animals; currently, no effective therapy is available for human infections. Combinations of sulfonamides with other antifolates, trimethoprim or pyrimethamine, are recommended therapy for Pneumocystis carinii pneumonia or toxoplasmosis, respectively. Therapies for the various types of leishmaniasis and trypanosomiasis are complex, often toxic, and often of limited efficacy. The benzimidazoles are effective for roundworm infections, although thiabendazole has severe toxic effects. The recent introduction of ivermectin has revolutionized the treatment and control of onchocerciasis. Another relatively new agent, praziquantel, is a true broad-spectrum anthelmintic agent that is effective against most trematodes, many adult cestodes, and larval cestodes as well (especially cysticerci of Taenia solium).

Clinical Use of Botulinum Toxin

Over the past 20 years, botulinum toxin has proved the treatment of choice for a number of symptoms and disorders. Its successful therapeutic use in certain other diseases, however, has been limited by lack of approval. In many indications ? for example headaches ? its value has not yet been definitely established. Botulinum toxin is meanwhile offered by four manufacturers, and we may expect additional preparations in future.

Methotrexate and Liver Biopsies

Methotrexate has been a valuable drug in the management of severe generalized psoriasis for over 35 years as pointed out in the article by Gilbert et al¹in this issue of theArchives. Gubner²described the benefit of aminopterin (precursor of methotrexate) in the clearing of psoriatic skin lesions See also p 889. in 1951 while using methotrexate to treat rheumatoid arthritis. This cancer chemotherapeutic drug became standard therapy for severe psoriasis from 1955 to 1972 despite its lack of approval by the Food and Drug Administration (FDA). In 1965, Roenigk et al³reported a new weekly dosage schedule of methotrexate for use in psoriasis. We found "a few minimal changes in hepatic function studies in eight of 45 psoriatics" receiving methotrexate. Since other authors were beginning to report methotrexate-induced hepatic injury, we cautioned that future followup studies were needed to determine the long-term effect of methotrexate