A5007655671- Biomedical Ethics and Regulation
- Ethics in Clinical Research
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Economics and Policy
- Pluripotent Stem Cells Research
- CAR-T cell therapy research
- Ethics and Legal Issues in Pediatric Healthcare
- Science, Research, and Medicine
- CRISPR and Genetic Engineering
- Pharmaceutical studies and practices
- Healthcare cost, quality, practices
- Genomics and Rare Diseases
- Ethics in medical practice
- Biomedical and Engineering Education
- Injury Epidemiology and Prevention
- LGBTQ Health, Identity, and Policy
- Migration, Health, Geopolitics, Historical Geography
- Public Health Policies and Education
- Neuroethics, Human Enhancement, Biomedical Innovations
- SARS-CoV-2 and COVID-19 Research
- Biotechnology and Related Fields
- Cancer Genomics and Diagnostics
- Traffic and Road Safety
- Reproductive Health and Technologies
- Economic and Financial Impacts of Cancer
New York University
2016-2024
Ethics and Public Policy Center
2021
Hinge Health
2021
Muhlenberg College
2019-2020
NYU Langone Health
2014-2019
Columbia University
2005-2019
Indiana University School of Medicine
2019
Case Western Reserve University
2019
University School
2019
University of Pennsylvania
2019
The scientific, ethical, and policy issues raised by research involving the engraftment of human neural stem cells into brains nonhuman primates are explored an interdisciplinary working group in this [Policy Forum][1]. authors consider possibility that might alter cognitive capacities recipient great apes monkeys, with potential significance for their moral status. [1]: http://www.sciencemag.org/cgi/content/full/309/5733/385
Fecal microbiota transplantation (FMT) has rapidly grown in notoriety and popularity worldwide as a treatment for both recurrent refractory C. difficile infection (CDI), well myriad of other indications, with varying levels evidence to justify its use. At present, FMT use the U.S. not received marketing approval from Food Drug Administration (FDA), but is permitted under “enforcement discretion” CDI responding standard therapy. Meanwhile, rising interest gut microbiome throughout mainstream...
If stem cells fulfill their therapeutic promise, moving them from the laboratory into clinic will raise several concerns about justice. One concern is that, for biological reasons alone, cell-based therapies might not be available every patient who needs one. Worse, depending on how we address problem of access, they benefit primarily white Americans. We can avoid this outcome—although at a cost—by carefully selecting make available.
Ideas and Opinions17 November 2015Right-to-Try Laws: Hope, Hype, Unintended ConsequencesAlison Bateman-House, PhD, MPH, MA, Laura Kimberly, MSW, MBE, Barbara Redman, Nancy Dubler, LLB, Arthur Caplan, PhDAlison MAFrom New York University Langone Medical Center Columbia School of Social Work, York, York., MBEFrom LLBFrom PhDFrom York.Author, Article, Disclosure Informationhttps://doi.org/10.7326/M15-0148 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack...
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Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that granted compassionate use, or 'preapproval', access to their investigational products done so without fanfare divulging the process grounds on which decisions were made. The number use requests has increased over time. Driving demand new treatments serious unmet medical needs; patient advocacy groups pressing emerging treatments;...
After witnessing extraordinary scientific and regulatory efforts to speed development of access new COVID-19 interventions, patients facing other serious diseases have begun ask "where's our Operation Warp Speed?" "why isn't Emergency Use Authorization an option for health crises?" Although this pandemic bears a number unique features, the response offers translatable lessons, in both its successes failures, non-pandemic diseases. These include importance collaborating across sectors,...
Medical school faculty and their colleagues in schools of nursing, public health, social work, elsewhere often research issues critical importance to health science policy. When academics engage with government policymakers advocate for change based on research, however, they may find themselves engaged "lobbying," thereby entering a complex environment legal requirements institutional policies that not fully understand. To promote academic advocacy, this article explains what is legally...
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In 2012, New York City Mayor Michael Bloomberg proposed capping the size of sugary beverages that could be sold in city's restaurants, sporting and entertainment facilities food carts. After a lawsuit multiple appeals, proposal died June 2014, deemed an unconstitutional overreach. dissecting saga soda cap, we highlight both political perils certain anti-obesity efforts and, more broadly, challenges to public health when issues consumer choice threat paternalism are involved.
In the US, gene therapy companies, as with all biopharmaceutical are not required by law or regulation to provide their investigational products patients via non-trial preapproval (expanded) access. However, we believe that in particular, have a moral obligation develop policies regarding such access, historically known "compassionate use." Gene therapies predominantly intended for serious life-threatening rare diseases which there limited treatments;1 this should compel companies...
For decades, the U.S. Food and Drug Administration (FDA) has provided an "expanded access" pathway that allows patients who meet qualifying conditions to gain access outside a clinical trial investigational medical product being tested see if it is safe effective for specific use. The Right Try (RTT) Act, enacted in 2018, created second mechanism off-trial, or non-trial, drugs. In contrast expanded pathway, federal RTT does not require involvement of FDA institutional review board (IRB)....
Duchenne muscular dystrophy (DMD) is a progressive, life-limiting, neuromuscular disorder. Clinicians play an important role in informing families about therapy options, including approved gene therapies and clinical trials of unapproved therapies.
SARS, avian flu, bioterrorism: such threats to national security at the dawn of 21st century have renewed anxieties about controlling disease nation's borders.Control infectious agents also provided impetus for immigrant medical inspections along U.S. coasts in late 19th century, but, practice, it was weeding out chronic and disability that actually motivated public health officers on "the line" Ellis Island other immigration stations during first 30 years federal control borders.From...