Assistant Secretary For Health Research Articles

Selected Developments in Biotechnology Law and the Biotechnology Industry

Selected Developments in Biotechnology Law and the Biotechnology Industry

Trump’s surprise rebate executive order would affect pharmacists and patients if enacted

Trump’s surprise rebate executive order would affect pharmacists and patients if enacted

A Summary of the 2020 Gastric Cancer Summit at Stanford University

There exists no coherent national strategy for the early detection or prevention of gastric cancer in the United States (US), even among identified high-risk groups such as Asian Americans, African Americans, Hispanic Americans, and Alaska Native/American Indian peoples. As a result, patients with gastric cancer in the US are diagnosed at later stages and demonstrate worse overall survival compared to nations of East Asia with established screening programs (Table 1). The under-recognition of gastric cancer risk within minority communities is a significant unaddressed healthcare disparity.

Creation of a network of military biological laboratories by the United States of America

In the article "US Biological Weapons - Myth or Reality?" from April 10, 2018 provides information about the conference held on March 7, 2018 in the European Parliament and was devoted to biosafety and readiness of Europe to the threat of biological weapons. It was attended by a well-known Bulgarian journalist Dilyana Gaitandzhieva, who conducted her own investigation into the activities of secret US biolaboratories. According to her, biological weapons are being developed at facilities operating under the guise of medical centers in 25 countries. During the conference, says Gaitandzhieva, she desperately tried to find out why the number of outbreaks of infections has risen sharply in the countries where American biolaboratories are located. First of all, Dilyana addressed the US Assistant Secretary of Health, Robert Kadlec, who spoke at the conference.

COVID-19 emergency responders in FDA’s Center for Drug Evaluation and Research

COVID-19 emergency responders in FDA’s Center for Drug Evaluation and Research

An Examination of the Clarity of Government Health Websites Using the Centers for Disease Control and Prevention's Clear Communication Index

This essay used a content analysis method, the Centers for Disease Control and Prevention research tool, the Clear Communication Index, to evaluate the understandability levels of 10 office and six agency’s health websites, under the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Health, which are designed for patients to have access to information about health interventions. The objective of this content analysis study was to measure the content of the 10 office websites and six agencies in terms of the clear communication of the health information. The results provide support that these websites do provide relevant health information to consumers and are designed to provide consumers with information support relevant to their health. These findings will help determine best practices for creating website content suitable for all health literacy levels, identify modifications to improve the index and build on previous literature in regard to the importance of using plain language in public health websites.

Physical rehabilitation therapists' perspective of the opioid crisis with evidence-based recommendations.

In 2017, the Secretary of Health and Human Services and Office of the Surgeon General declared the opioid crisis of our nation to be a public health emergency. In response to the Office of the Assistant Secretary of Health and Office of the Surgeon General's 'Call to Action', the Therapist category of the US Public Health Service commissioned a nine-member task force consisting of pain science subject matter experts to study the Therapists' role in effectively reducing chronic pain and opioid abuse. This article addresses the opioid epidemic, how patients with chronic pain have been managed inappropriately, and five key, evidence-based recommendations from this task force.

Scheduling synthetic cathinone substances under the Controlled Substances Act.

Cathinones are amphetamine analogues that produce stimulant effects with rewarding properties. For many decades, synthetic cathinones have been used in the United States (USA) for abuse purposes, leading to concern about public safety by the federal government. Under the Controlled Substances Act (CSA), the federal government may place drugs with high abuse potential but no currently accepted medical use into Schedule I of the CSA. The process of scheduling an abusable drug involves both the Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), and the Department of Justice, through the Drug Enforcement Administration (DEA). This paper details how numerous synthetic cathinones were placed under CSA control between 1973 and 2018, with an emphasis on 10 cathinones that were placed into Schedule I in 2017 (butylone, naphyrone, pentylone, pentedrone, 3-fluoro-N-methylcathinone (FMC), 4-FMC, 4-methyl-N-ethylcathinone, 4-methyl-pyrrolidinopropiophenone, alpha-pyrrolidinobutiophenone, and α-pyrrolidinopentiophenone). A summary is provided of the scientific and medical analysis performed by HHS, in the form of an Eight-Factor Analysis (8FA), as prescribed by the CSA. This 8FA was then evaluated and signed by the Assistant Secretary for Health at HHS and transmitted to DEA, which permanently placed the 10 cathinones into Schedule I after public notices were published into the Federal Register. Understanding the scientific data, analysis, and complex process utilized by the US federal government in the CSA scheduling of cathinones with abuse potential and no accepted medical use is important for transparency in governmental decision-making.

Drugmakers Vow to Donate Take-Home Naloxone While Prices for Drug Soar

Drugmakers Vow to Donate Take-Home Naloxone While Prices for Drug Soar

States Pilot New Medicaid Substance Use Treatment Plans

States Pilot New Medicaid Substance Use Treatment Plans

Federal Public Health Service: In Retrospect and Prospects.

In this article, I offer a retrospective case study about my early, short-term work within the U.S. Office of the Assistant Secretary for Health and then my later, longer-term work within the U.S. Centers for Disease Control and Prevention, where I endeavored for two decades largely to help our nation's schools improve health and associated education outcomes. First, for context, I briefly portray the nature of our related political and public health systems. I then frame this retrospective by illustrating how my serial employment within other public health system organizations led to, and then resulted from, my work within these two federal public health agencies. To represent the many talented individuals in each organization with whom I had the good fortune to work, I name only one in each organization. I then characterize how these individuals and organizations progressively shaped my work and career. I conclude by speculating about prospects for academic institutions to more purposefully prepare students and faculty to work within federal government public health agencies.

HHS releases plan aimed at increasing adult immunizations

T National Vaccine Program Office (NVPO), a core public health office within the Office of the Assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS), recently released a National Adult Immunization Plan (NAIP) that offers a framework for increasing the number of adults in the United States who receive immunizations against preventable—and potentially deadly—diseases.

Community Colleges and Public Health

The Association of Schools and Programs of Public Health’s Framing the Future Task Force and the League for Innovation in the Community College (the League) cosponsored the Community Colleges and Public Health report. The report recommends that community colleges consider offering public health associate degrees and academic certificate programs including two prototype curricular models developed with support from the Office of the Assistant Secretary for Health of the U.S. Department of Health and Human Services. These include Public Health: Generalist & Specializations and Health Navigator. Each model includes 30 semester hours of coursework in public health core, required courses, experiential learning, and electives along with content outlines for public health core and specialty coursework. The report has been approved by the Association of Schools and Programs of Public Health’s Board and widely disseminated by the League. The League is currently implementing a planning and recognition process to encourage community colleges to plan associate degree and academic certificate programs consistent with the report including both prototype curricular frameworks. The Public Health: Generalist & Specializations is designed for transfer to bachelor’s degree programs in general public health, health education, health administration, and environmental health. The Health Navigator programs are designed for employment as community health workers, health care/patient navigators, and/or health insurance navigators. The rapidly expanding job market for these fields is discussed as well as the recommendation that these associate degrees be planned to enable transfer to bachelor’s degree programs in health education. Implications for the future of the health education profession are also addressed.

Reflections on Government Service Rotations by an Academic Health Education Professional.

This reflection is on a health education professional's rotation from professor in a school of public health to a government position and back parallels that of Professor Howard Koh's journey to Assistant Secretary of Health, one level higher in the same federal bureaucracy. We both acknowledge the steep learning curve and some bureaucratic hassles and mazes that can attend government service, but similarly conclude that ". . . it was worth it." In this personalized case, I weigh some of the specific learning experiences and challenges I faced while in the government against the needs of the field of health promotion for more such revolving-door experiences among academic public health professionals. From my argument that to get more evidence-based practice we need more practice-based evidence, I conclude that more experience in practice among those returning to academia will render their teaching and research more relevant to the needs for evidence in policy and practice.

Strengthening the U.S. Public Health Service Commissioned Corps: A View From The Assistant Secretary for Health.

To summarize the results of the major management review of the U.S. Public Health Service Commissioned Corps (2009-2010) and note related outcomes. Narrative from the U.S. Assistant Secretary for Health, who directed and oversaw the management review. The management review led to 46 recommendations, all of which have since been implemented. The subsequent organizational and operational changes have unified reporting structures, streamlined the administrative Corps organizational structure, and transferred support services to providers with expertise in uniformed services to create a new integrated personnel and payroll system. Related processes have also prompted a systematic billet review as well as establishment of explicit criteria for eligibility to become a Corps officer. Corps leaders report improvements in recruiting talented officers, increased selectivity from the candidate pool, and enhanced matching of incoming officers with agency assignments. Furthermore, Corps activity has grown in both traditional and innovative ways. The Corps has enjoyed heightened activity and outcomes in the era of health reform. The management review and its implementation have strengthened the Corps, helping officers to do their job and achieve their mission.

Q&A: Howard Koh on Smoking Cessation and Policy

To mark the 50th anniversary of the Surgeon General's first report on smoking and health, and to promote this year's report, Howard Koh, MD, MPH, assistant secretary for health at the U.S. Department of Health and Human Services, spoke about the importance of and the continuing need for tobacco-control efforts.

Hero: David Satcher, MD, PhD

Hero:David Satcher, MD, PhD Claudia R. Baquet, MD, MPH (bio) David Satcher, MD, PhD is the founder of the Journal of Health Care for the Poor and Underserved, the premier journal on health and related topics on low-income and medically underserved populations. Dr. Satcher is a physician scholar with a legacy of excellence in public health, clinical medicine, and health policy. In 1998, he was appointed the 16th Surgeon General by President Clinton. Dr. Satcher served simultaneously in the positions of Surgeon General and Assistant Secretary for Health from February 1998 through January 2001. He also held the posts of Director of the Centers for Disease Control and Prevention and Administrator of the Agency for Toxic Substances and Disease Registry from 1993 to 1998. Before joining the Administration, he was President of Meharry Medical College in Nashville, Tennessee, from 1982 to 1993. It was during his tenure as President of Meharry that he founded the Journal of Health Care for the Poor and Underserved. Since 2006, he has served as Director of The Satcher Health Leadership Institute at the Morehouse School of Medicine in Atlanta, Georgia. The mission of the Institute parallels Dr. Satcher’s commitment to and experience in fostering leadership in public health. The Institute supports the development of a diverse group of public health leaders, fosters and supports leadership strategies, and influences public policies related to the reduction and ultimate elimination of disparities in health. The Institute’s programs reflect Dr. Satcher’s experience in improving public health policy and his commitment to eliminating health inequities for underserved groups while at the same time shedding light on neglected issues, such as mental and sexual health. Under his leadership as Surgeon General, significant and landmark public health policy transformed the nation. He focused national attention on the importance of mental health as a legitimate health concern. Surgeon General Satcher’s reports and related documents are listed below. Surgeon General Satcher’s Reports and Related Documents [End Page 1] Click for larger view View full resolution David Satcher, MD, PhD 2001 January Report of the Surgeon General’s Conference on Children’s Mental Health: A National Action Agenda January Youth Violence: A Report of the Surgeon General March Women and Smoking: A Report of the Surgeon General May National Strategy for Suicide Prevention June The Surgeon General’s Call to Action to Promote Sexual Health and Responsible Sexual Behavior August Mental Health: Culture, Race, and Ethnicity December Call to Action to Decrease and Prevent Overweight and Obesity 2000 August Reducing Tobacco Use: A Report of the Surgeon General May Oral Health in America: A Report of the Surgeon General October HHS Blueprint for Action on Breastfeeding 1999 June The Surgeon General’s Call to Action to Prevent Suicide December Mental Health: A Report of the Surgeon General. In addition to serving as the 16th Surgeon General of the United States in 1998, Dr. Satcher also served as Assistant Secretary for Health in the Department of Health and Human Services from February 1998 to January 2001, making him only the second person in history to have simultaneously held both positions. As noted above, his tenure of public service also includes serving as Director of the Centers for Disease Control and Prevention (CDC) and Administrator of the Toxic Substances and Disease Registry from 1993 to 1998. He was the first person to have served as Director of the CDC and then Surgeon General of the United States. During his tenure leading the CDC, some highlights of Dr. Satcher’s leadership include these: • Led the National effort increasing childhood immunization by age two from 50% in 1993 to 78% in 1996. • Led expansion of breast and cervical cancer screening programs from 18 states in 1993 to all 50 states, six territories and 15 American Indian Reservations by 1998. [End Page 2] • Led establishment of strategy for control of emerging infectious diseases. Including: 1) Launching of Journal of Emerging Infectious Diseases as the first scientific journal to be launched electronically or online and 2) Chaired Committee of the State Department that developed A Global Strategy for the Control of Emerging Infectious Diseases—Presidential Directive #96. • Led establishment of centralized HIV/AIDS...

Remarks from David Satcher, M.D., Ph.D., Assistant Secretary for Health and Surgeon General.

Remarks from David Satcher, M.D., Ph.D., Assistant Secretary for Health and Surgeon General.

Scientific Misconduct and Research Integrity for the Bench Scientist

This paper describes the role of the Office of Research Integrity (ORI), a component of the Public Health Service (PHS), in defining scientific misconduct in research supported with PHS funds and in establishing standards for responding to allegations of misconduct. The principal methods by which ORI exercises its responsibilities in this area are defining what types of behaviors undertaken by research investigators constitute misconduct, overseeing institutional efforts to Investigate and report misconduct, and recommending to the Assistant Secretary for Health (ASH) PHS administrative actions when misconduct is identified. ORI also takes affirmative steps to promote research integrity through education, training, and other initiatives. The role of the research institution in responding to misconduct and promoting research integrity is complementary and overlapping with ORI's efforts but, as the employer of research investigators and front-line manager of the research, the institution has a greater oppor...

Coping with the HIV epidemic 1982–2007: 25‐year outcomes of the Hershey Haemophilia Cohort

Coping with the HIV epidemic 1982–2007: 25‐year outcomes of the Hershey Haemophilia Cohort