Medicines that Work for Fibromyalgia

2002 ◽  
Author(s):  
Daniel J. Wallace ◽  
Janice Brock Wallace
Keyword(s):  
United States ◽  
The United States ◽  
Regulatory Control ◽  
Insurance Companies ◽  
Controlled Trials ◽  
Fda Approval ◽  
Or Groups ◽  
Natural Remedies ◽  
Antianxiety Drug ◽  
Double Blinded

Nobody likes to take medicine. Many fibromyalgia patients, in particular, prefer to treat their condition with natural remedies, and many are reluctant to take prescribed medication. This problem is made more difficult because many of the most helpful preparations are designated as antidepressants. Some patients become concerned that this might create a stigma. “If you really believe what I am saying, and are convinced that I am not crazy, why are you giving me an antidepressant or antianxiety drug?” is a question we frequently hear. This problem is compounded when some insurance companies refuse to reimburse patients for these preparations, claiming that they are uncovered “psychiatric benefits.” Management of fibromyalgia includes medications from separate families or groups, in which at least one agent has been shown in double-blinded, controlled trials (where some of the study subjects get placebo, or sugar pills) to be effective in fibromyalgia patients. The rationale for using these drugs in treating fibromyalgia is reviewed in this chapter, but first the scientific logic behind putting these drugs on our “A” list will be discussed. In the United States, the Food and Drug Administration (FDA) approves drugs for specific indications. It takes many years and many dollars for an agent to be approved for a specific use, and since fibromyalgia was not recognized as a disorder until 1990, no drugs currently have FDA approval for the condition. Many of the remedies purported to help fibromyalgia are beyond the FDA’s regulatory control. These include a variety of vitamins and agents that are licensed as food supplements. As a result, promising preparations such as DHEA and melatonin (reviewed in chapter 22) are widely available without a prescription and are being taken by patients even though few controlled trials have documented their safety or efficacy. For example, there is no legal obligation to prove that a 3-mg tablet of melatonin really contains 3 mg. Also, each batch of medication can be mixed with varying preservatives, which may affect its delivery, or bioavailability. Some of our patients have no difficulty taking the medication but react to its packaging. Physicians who manage fibromyalgia patients must rely on scientific studies showing that a drug is effective in alleviating a particular condition.

scholarly journals Clinical impact of pharmacist-led antibiotic stewardship programs in outpatient settings in the United States: A scoping review

2021 ◽  
Author(s):  
James St. Louis ◽  
Arinze Nkemdirim Okere
Keyword(s):  
United States ◽  
Usual Care ◽  
Antibiotic Stewardship ◽  
The United States ◽  
Controlled Trials ◽  
Antibiotic Prescribing ◽  
Successful Implementation ◽  
Pharmacist Interventions ◽  
Outpatient Settings ◽  
The Impact

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose To provide an overview of the impact of pharmacist interventions on antibiotic prescribing and the resultant clinical outcomes in an outpatient antibiotic stewardship program (ASP) in the United States. Methods Reports on studies of pharmacist-led ASP interventions implemented in US outpatient settings published from January 2000 to November 2020 and indexed in PubMed or Google Scholar were included. Additionally, studies documented at the ClinicalTrials.gov website were evaluated. Study selection was based on predetermined inclusion criteria; only randomized controlled trials, observational studies, nonrandomized controlled trials, and case-control studies conducted in outpatient settings in the United States were included. The primary outcome was the observed differences in antibiotic prescribing or clinical benefits between pharmacist-led ASP interventions and usual care. Results Of the 196 studies retrieved for full-text review, a cumulative total of 15 studies were included for final evaluation. Upon analysis, we observed that there was no consistent methodology in the implementation of ASPs and, in most cases, the outcome of interest varied. Nonetheless, there was a trend toward improvement in antibiotic prescribing with pharmacist interventions in ASPs compared with that under usual care (P < 0.05). However, the results of these studies are not easily generalizable. Conclusion Our findings suggest a need for a consistent approach for the practical application of outpatient pharmacist-led ASPs. Managed care organizations could play a significant role in ensuring the successful implementation of pharmacist-led ASPs in outpatient settings.

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

The Pioneer in American Life Insurance Marketing

1938 ◽  
Vol 12 (5) ◽  
pp. 65-75
Author(s):  
J. Owen Stalson
Keyword(s):  
United States ◽  
Eighteenth Century ◽  
North America ◽  
Life Insurance ◽  
General Public ◽  
Colonial America ◽  
The United States ◽  
Insurance Companies ◽  
Insurance Company ◽  
Fire Insurance

Colonial America gave little thought to life insurance selling. The colonists secured protection against marine risks from private underwriters, first in London, eventually at home. It has been asserted that Philadelphia had no fire insurance until 1752; Boston none before 1795. The first corporations formed in this country for insuring lives were those of the Presbyterian Ministers Fund (1759) and a similar company organized for the benefit of Episcopal ministers (1769). Neither of these corporations offered insurance to the general public. In the last decade of the eighteenth century many insurance companies were formed in the United States. At least five were chartered to underwrite life risks, but only one, The Insurance Company of North America, appears to have accepted any. There is no basis for saying that any of these early companies tried to sell life insurance.

scholarly journals Utilization of Positive Deviance into Research Activity for Community Health

2019 ◽  
pp. 1
Author(s):  
Harumi Bando ◽  
Mayumi Mizutani
Keyword(s):  
United States ◽  
The United States ◽  
Positive Deviance ◽  
Community Leaders ◽  
Local Problem ◽  
Health Providers ◽  
Community Members ◽  
Research Activity ◽  
Or Groups ◽  
Activity Report

The Positive Deviance (PD) approach believes that in every community there exist individuals or groups, who without any extra resources, practice uncommon behaviors that offer better solutions to addressing problems in a community. PD is a community-driven change approach that encourages community members to discover their own assets, strengths, and wisdom to solve a local problem. The purpose of this activity report is to describe the lessons we learned about PD during a visit with pioneering global researchers and practitioners of positive deviance in the United States in September, 2018. Our key learning included: discovering “uncommon” behaviors which are already practiced by community members, and are thus actionable and more acceptable to community members; investigating positive deviants at many levels i.e., among health providers, community leaders, and the ordinary population; and the importance of designing, from the very beginning, a project that invites and engages all community members who through ownership can sustain impact.

Circumcision Decision: Prominence of Social Concerns

PEDIATRICS ◽  
1987 ◽  
Vol 80 (2) ◽  
pp. 215-219
Author(s):  
Mark S. Brown ◽  
Cheryl A. Brown
Keyword(s):  
United States ◽  
Parental Education ◽  
The United States ◽  
Self Concept ◽  
Obstetrics And Gynecology ◽  
Controlled Trials ◽  
American Academy Of Pediatrics ◽  
Social Concerns ◽  
Policy Statements ◽  
Medical Indications

Despite policy statements against routine circumcision of newborns by the American Academy of Pediatrics and the American College of Obstetrics and Gynecology more than 10 years ago, there has been virtually no change in circumcision practices in the United States. In addition, controlled trials of programs to educate parents about the lack of medical indications for routine newborn circumcision have shown that parental education has little impact on the circumcision decision. We hypothesized that parents based their circumcision decision predominantly on social concerns rather than on medical ones. We prospectively surveyed parents of 124 newborns soon after they made the circumcision decision to learn their reasons for the decision. The strongest factor associated with the circumcision decision was whether or not the father was circumcised (P.0001). The survey also showed that concerns about the attitudes of peers and their sons' self concept in the future were prominent among parents deciding to circumcise. The circumcision decision in the United States is emerging as a cultural ritual rather than the result of medical misunderstanding among parents. In counseling parents making the circumcision decision, the health care provider should provide a knowledgeable and honest discussion of the medical aspects of circumcision. Until information is available that addresses parents' social concerns about circumcision, it is unreasonable to expect a significant change in circumcision customs in the United States.

scholarly journals On Legislation as to Life Insurance and Life Insurance Companies

1871 ◽  
Vol 16 (2) ◽  
pp. 77-98 ◽  
Author(s):  
T. B. Sprague
Keyword(s):  
United States ◽  
United Kingdom ◽  
Life Insurance ◽  
United States Of America ◽  
The United States ◽  
Insurance Companies ◽  
The Past ◽  
Life Assurance ◽  
The United Kingdom ◽  
The Law

The past session of Parliament has witnessed the passing of an Act for the regulation of Life Assurance Companies in the United Kingdom, which, while introducing great changes in the law, still stops very far short of the system of legislation which has been for several years in operation in a few of the United States of America, and which is warmly approved of and urgently recommended for adoption by some persons in this country. The present may therefore be considered a fitting time for reviewing what has been done and considering whether any further legislation is desirable, and if any, of what nature it should be.

scholarly journals National Trends in Hospitalizations for Sickle Cell Disease in the United States Following the FDA Approval of Hydroxyurea, 1998–2008

Medical Care ◽  
2014 ◽  
Vol 52 (7) ◽  
pp. 612-618 ◽  
Author(s):  
Maureen M. Okam ◽  
Shimon Shaykevich ◽  
Benjamin L. Ebert ◽  
Alan M. Zaslavsky ◽  
John Z. Ayanian
Keyword(s):  
United States ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
The United States ◽  
Cell Disease ◽  
Fda Approval ◽  
National Trends
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