Faster Access to Drugs for Serious or Life-Threatening Illnesses Through use of the Accelerated Approval Regulation in the United States

1998 ◽  
Vol 32 (1) ◽  
pp. 27-35 ◽  
Author(s):  
David M. Cocchetto ◽  
Douglas R. Jones
Keyword(s):  
United States ◽  
The United States ◽  
Life Threatening ◽  
Accelerated Approval

Acute Coronary Syndromes

2014 ◽  
pp. 806-818
Author(s):  
Susan Cheng ◽  
Marc S. Sabatine
Keyword(s):  
United States ◽  
Recurrent Events ◽  
Hospital Admissions ◽  
The United States ◽  
Threatening Condition ◽  
Life Threatening ◽  
Coronary Syndromes ◽  
Artery Disease ◽  
Ventricular Dysrhythmias ◽  
Key Aspects

In total, ACS presentations account for over 2 million annual hospital admissions in the United States. Almost 1.4 million people suffer an ACS each year, of which 55% are new events, 31% are recurrent events, and 14% are silent events. Of all diagnosed MIs, approximately 30% are STEMI and 70% are NSTE-ACS events. Despite recent declines in associated mortality, coronary artery disease causes one out of every five deaths in the United States. Notably, half of MI-related deaths occur within the first hour, primarily due to ventricular dysrhythmias. Therefore, the presentation of ACS challenges the clinician to rapidly integrate key aspects of the history, physical examination, and diagnostic tests in order to diagnose correctly and manage effectively this potentially life-threatening condition.

scholarly journals Plague and Pregnancy: Why Special Considerations Are Needed

2020 ◽  
Vol 70 (Supplement_1) ◽  
pp. S27-S29
Author(s):  
Dana Meaney-Delman ◽  
Nadia L Oussayef ◽  
Margaret A Honein ◽  
Christina A Nelson
Keyword(s):  
Public Health ◽  
United States ◽  
At Risk ◽  
Pregnant Women ◽  
Yersinia Pestis ◽  
The United States ◽  
Highly Pathogenic ◽  
Pathogenic Organism ◽  
Public Health Emergencies ◽  
Life Threatening

Abstract Pregnant women are an important at-risk population to consider during public health emergencies. These women, like nonpregnant adults, may be faced with the risk of acquiring life-threatening infections during outbreaks or bioterrorism (BT) events and, in some cases, can experience increased severity of infection and higher morbidity compared with nonpregnant adults. Yersinia pestis, the bacterium that causes plague, is a highly pathogenic organism. There are 4 million births annually in the United States, and thus the unique needs of pregnant women and their infants should be considered in pre-event planning for a plague outbreak or BT event.

scholarly journals Deaths from necrotizing fasciitis in the United States, 2003–2013

2015 ◽  
Vol 144 (6) ◽  
pp. 1338-1344 ◽  
Author(s):  
N. ARIF ◽  
S. YOUSFI ◽  
C. VINNARD
Keyword(s):  
United States ◽  
Necrotizing Fasciitis ◽  
Incidence Rate ◽  
Racial Differences ◽  
Cause Of Death ◽  
The United States ◽  
Crude Mortality Rate ◽  
Crude Mortality ◽  
Icd 10 ◽  
Life Threatening

SUMMARYNecrotizing fasciitis (NF) is a life-threatening infection requiring urgent surgical and medical therapy. Our objective was to estimate the mortality burden of NF in the United States, and to identify time trends in the incidence rate of NF-related mortality. We obtained data from the National Center for Health Statistics, which receives information from death certificates from all states, including demographic information and cause of death. The U.S. Multiple Cause of Death Files were searched from 2003 to 2013 for a listing of NF (ICD-10 code M72.6) as either the underlying or contributing cause of death. We identified a total of 9871 NF-related deaths in the United States between 2003 and 2013, corresponding to a crude mortality rate of 4·8 deaths/1 000 000 person-years, without a significant time trend. Compared to white individuals, the incidence rate of NF-associated death was greater in black, Hispanic, and American Indian individuals, and lower in Asian individuals. Streptococcal infection was most commonly identified in cases where a pathogen was reported. Diabetes mellitus and obesity were more commonly observed in NF-related deaths compared to deaths due to other causes. Racial differences in the incidence of NF-related deaths merits further investigation.

scholarly journals Misoprostol-induced Coronary Vasospasm Complicated by Takotsubo Cardiomyopathy and Cardiac Arrest

2021 ◽  
Author(s):  
Parminder Kaur ◽  
Melvin Santana ◽  
Balraj Singh ◽  
Anuraag Sah ◽  
Raja Pullatt ◽  
...  
Keyword(s):  
United States ◽  
Adverse Event ◽  
Cardiac Arrest ◽  
Takotsubo Cardiomyopathy ◽  
Coronary Artery Spasm ◽  
The United States ◽  
Endometrial Ablation ◽  
Coronary Vasospasm ◽  
Life Threatening ◽  
Induce Abortion

Misoprostol is a synthetic E1 prostaglandin commonly used to induce abortion in the United States and elsewhere. There is limited literature on the cardiovascular adverse effects of misoprostol, and, to the best of our knowledge, very few such events have been reported. We describe the case of 52-year-old woman who was given misoprostol for cervical softening before endometrial ablation and experienced a cardiac arrest due to coronary vasospasm. She was successfully resuscitated and echocardiography showed features consistent with Takotsubo cardiomyopathy. Coronary angiography revealed coronary artery spasm which responded to nitroglycerin. Our case adds to the limited literature on this life-threatening adverse event of misoprostol.

scholarly journals Positive Women: Emotion, Memory, and the Power of Narrative in Women Organized to Respond to Life-Threatening Diseases, 1991-2020

2020 ◽  
pp. 46-93
Author(s):  
Eleanor Naiman
Keyword(s):  
United States ◽  
The United States ◽  
People Of Color ◽  
Hiv Diagnosis ◽  
Aids Epidemic ◽  
Fda Approval ◽  
Published Report ◽  
Life Threatening ◽  
Emotion Memory ◽  
Personal Fulfillment

Note: In lieu of an abstract, this is the article's first paragraph. "By 1992, the AIDS epidemic in the United States had reached seemingly catastrophic proportions. Over ten years after the first published report of AIDS-related lung infection, the number of AIDS cases in the United States far exceeded 100,000. It would be four years until the FDA approval of the first protease inhibitor. Over ten thousand women had been diagnosed with the disease, and experts expected over ninety thousand more were already infected. The disease, lacking effective treatment, increasingly struck women and people of color in the early 1990s; cases rose 151 percent among women and by 105 percent among men in 1993. Without a cure in sight, women with HIV did not have much tangible reason for optimism. Nonetheless, in January 1992 Debra McCarthy cast her HIV diagnosis as the turning point in her journey towards personal fulfillment. “Even though I may be HIV positive,” she wrote, “I am more healed in my life than I ever have been.”"

Use of pneumococcal vaccine in children

PEDIATRICS ◽  
1978 ◽  
Vol 61 (2) ◽  
pp. 321-322
Author(s):  
Jerome O. Klein ◽  
Edward A. Mortimer
Keyword(s):  
United States ◽  
Pneumococcal Disease ◽  
The United States ◽  
Polysaccharide Vaccine ◽  
Turn Of The Century ◽  
Cell Vaccine ◽  
Pneumococcal Polysaccharide Vaccine ◽  
Life Threatening ◽  
Whole Cell Vaccine ◽  
Gold Miners

A 14-type pneumococcal polysaccharide vaccine has been licensed for use in the United States (Pneumovax, Merck & Co., Inc.). Although there are more than 80 immunologically distinct capsular types of pneumococci, the strains incorporated into the vaccine have been responsible for approximately 80% of the cases of serious pneumococcal disease in the United States in recent years. The vaccine should be of value for selected children at risk for severe or life-threatening disease due to the pneumococcus. Pneumococcal vaccines have been used since the turn of the century. In 1914, Sir Almroth Wright* and colleagues reported favorable results of a whole cell vaccine administered to gold miners in South Africa.1

Pepper-Spray-induced Respiratory Failure Treated With Extracorporeal Membrane Oxygenation

PEDIATRICS ◽  
1996 ◽  
Vol 98 (5) ◽  
pp. 961-963
Author(s):  
Deborah F. Billmire ◽  
Charles Vinocur ◽  
Maureen Ginda ◽  
Nancy B. Robinson ◽  
Howard Panitch ◽  
...  
Keyword(s):  
United States ◽  
Respiratory Failure ◽  
Extracorporeal Membrane Oxygenation ◽  
The United States ◽  
Accidental Exposure ◽  
Membrane Oxygenation ◽  
Self Defense ◽  
Lack Of Information ◽  
Life Threatening ◽  
Serious Injury

Self-defense sprays have been available to the general public since the 1970s. They are easily obtained and over 6 million spray units were sold in the United States in 1993 alone. The intent of these sprays is to cause skin and mucosal irritation without producing serious injury. We describe the accidental exposure to pepper-gas spray of an infant who experienced immediate life-threatening respiratory distress followed by progressive deterioration. Ultimately, he required extracorporeal membrane oxygenation (ECMO) for survival. The decision to place the infant on ECMO was made more difficult by the lack of information about potential reversibility with this rare toxic cause of respiratory failure.

The Role of Physical Therapists Within Hospice and Palliative Care in the United States and Canada

2016 ◽  
Vol 34 (1) ◽  
pp. 34-41 ◽  
Author(s):  
Christopher M. Wilson ◽  
Christine H. Stiller ◽  
Deborah J. Doherty ◽  
Kristine A. Thompson
Keyword(s):  
United States ◽  
Palliative Care ◽  
Data Analysis ◽  
Physical Therapy ◽  
Physical Therapists ◽  
The United States ◽  
Direct Patient Care ◽  
Life Threatening ◽  
Hospice And Palliative Care

Purpose: Little is known regarding the extent to which physical therapy is integrated into Hospice and Palliative Care (HPC). The purpose of this study was to describe perceptions of physical therapists (PTs) regarding their role within HPC or working with patients having life-threatening illnesses and to develop a conceptual framework depicting a PTs role within HPC and factors affecting it. Participants: Ten PTs, 5 from the United States and 5 from Canada, with at least 5 years of physical therapy experience and 5 years working experience with patients having life-threatening illnesses or in HPC. Methods: Demographic data were collected by electronic questionnaire. A semistructured interview was conducted with each participant to investigate their perceptions about the role of PTs in HPC. Data Analysis: Interview results were analyzed for trends between participants, practice settings, regions, and other sociocultural aspects. The constant comparative method of qualitative data analysis was used to identify similarities and differences and to develop themes and concepts relative to the role of PT in HPC. Results: Participants identified their 3 primary roles in HPC: providing patient/family care, serving as an interdisciplinary team member, and fulfilling professional responsibilities outside of direct patient care. They described factors within and outside direct patient care which influenced their roles. Concepts included shifting priorities, care across the continuum, and changing perceptions of PTs within HPC. Clinical Relevance: This study described perceptions of the role of PTs within HPC that may be utilized when coordinating future strategies to appropriately promote and expand the role.

scholarly journals Proteinuria Reduction as a Surrogate End Point in Trials of IgA Nephropathy

2019 ◽  
Vol 14 (3) ◽  
pp. 469-481 ◽  
Author(s):  
Aliza Thompson ◽  
Kevin Carroll ◽  
Lesley A. Inker ◽  
Jürgen Floege ◽  
Vlado Perkovic ◽  
...  
Keyword(s):  
Iga Nephropathy ◽  
Time Course ◽  
Treatment Effects ◽  
The United States ◽  
End Points ◽  
End Point ◽  
Long Time ◽  
Life Threatening ◽  
Accelerated Approval

IgA nephropathy (IgAN) is an important cause of ESKD for which there are no approved therapies. A challenge for evaluating treatments for IgAN is the usual long time course for progression to ESKD. The aim of this Kidney Health Initiative project was to identify surrogate end points that could serve as reliable predictors of a treatment’s effect on long-term kidney outcomes in IgAN and be used as a basis for approval. Proteinuria was identified as the most widely recognized and well studied risk factor for progression to ESKD in IgAN. The workgroup performed a critical review of the data on proteinuria reduction as a surrogate end point for a treatment’s effect on progression to ESKD in IgAN. Epidemiologic data indicate a strong and consistent relationship between the level and duration of proteinuria and loss of kidney function. Trial-level analyses of data from 13 controlled trials also show an association between treatment effects on percent reduction of proteinuria and treatment effects on a composite of time to doubling of serum creatinine, ESKD, or death. We conclude that data support the use of proteinuria reduction as a reasonably likely surrogate end point for a treatment’s effect on progression to ESKD in IgAN. In the United States, reasonably likely surrogate end points can be used as a basis for accelerated approval of therapies intended to treat serious or life-threatening conditions, such as IgAN. The clinical benefit of products approved under this program would need to be verified in a postmarketing confirmatory trial.

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