A History of the National Academy of Medicine 50 Years of Transformational Leadership (2022) / Chapter Skim
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4 Biomedical Science
4 Biomedical Science
Pages 63-100
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From page 63... ...
. In addition to guiding the development and application of biomedical science and many other fields, the organization maintains a focus on the implications 63
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Due to restrictions on federal funding in this area, privately funded research was being carried out without a set of clearly defined and unified guide lines or regulations. In 2005, the IOM released its first set of guidelines for research with human embryonic stem cells, which included ethical and scientific considerations (IOM and NRC, 2005)
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THE HUMAN GENOME: FROM SEQUENCING TO EDITING Alongside the NAS, the IOM played a leading role in the human genome sequencing project from its very beginnings in the late 1980s. Today, the NAM continues to be a driving force in current discussions about the rapidly developing field of human genome editing.
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. The NAM, along with the NAS, The Royal Society of the United Kingdom, and the Chinese Academy 1 Evaluation of Impact from IOM Reports (Database)
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NAM President Victor Dzau signed a statement in which he and his fellow Academy presidents welcomed the call "to continue to lead a global discussion on issues related to human gene editing" (Cicerone et al., 2015)
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In 2017, the NAS and the NAM jointly issued a consensus report called Human Genome Editing: Science, Ethics, and Governance, which continued the discussion from the 2015 summit. The report offered a set of principles for the governance of human genome editing, including the promotion of "well-being, transparency, due care, responsible science, respect for persons, fairness, and transnational cooperation." These principles informed the recommendation that research and clinical trials that involved somatic gene editing be limited to the prevention and treatment of disease and disability.
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. In 1977, the IOM released a report called Evaluation of Poliomyelitis Vaccines: Report of the Committee for the Study of Poliomyelitis Vaccines, which studied the relative merits of the two widely available polio vaccines.
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Once again, the IOM found itself as a mediator of scientific and public debate. The IOM released Immunization Safety Review: Vaccines and Autism in 2004, marking the culmination of an immunization safety project that had been funded by the CDC and the National Institutes of Health (NIH)
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• Immunization Safety Review: Multiple Immunizations and Immune Dysfunction (2002) • Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders (2002)
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The immunization safety review series played an important part in public discourse and immunization policy decisions in the United States at a critical time. The series provided state and federal government agencies with a balanced, scientific assessment of the risks associated with vaccines, and it provided public health and medical authorities a scientific foundation to rebut controversial theories about the safety of vaccines, specifically those related to autism.13 Studying vaccine safety became an ongoing activity, not only because of recurring vaccine scares but also because of changes in the disease and political environments.
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As research on brain development and gene– environment interactions evolved, the organization quickly identified the potential lifelong impact of these interactions, especially exposures and life circumstances from before birth through adolescence. Over time the organization cultivated a body of work dedicated to advancing the science of childhood and adolescent development with a concentration on the complex interactions across a constellation of biological, social, behavioral, and environmental factors.
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. What distinguished this report from previous work in this area was that it brought together the latest scientific research on brain development with recent findings in social science on environmental influences on childhood development.
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. Health Equity and Development Continuing its commitment to advancing the science of childhood development with an emphasis on complex biological, social, and environmental interactions, the National Academies released a report in 2019 called Vibrant and Healthy Kids: Aligning Science, Practice, and Policy to Advance Health Equity (NASEM, 2019d)
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DeVoe,21 concluded that "reducing health disparities by addressing their systemic root causes, including poverty and racism, is foundational to advance health equity" (NASEM, 2019c, p.
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, produced numerous consensus reports focused on childhood development and wellbeing over the years, such as those listed in Box 4-3. FACILITATING PROGRESS IN CANCER RESEARCH Cancer is a collection of complex diseases that manifest themselves in different ways in different individuals at any point throughout one's lifespan.
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Over the years, the National Cancer Policy Board/Forum served as the organization's driving force for discourse on advancing cancer research -- from improving clinical trials to leveraging informatics and nanotechnology in research. Box 4-4 provides examples of the research-oriented publications released by the National Cancer Policy Board/Forum.
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Cancer Research and Drug Development As described below and in previous chapters, the IOM and later the HMD have had a long history with the NIH in which the IOM provided advice to the NIH on its research agenda and strategies to ensure progress and equity in scientific research. For example, in 1999 the IOM released a report called The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved.
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Following the release of the 2010 report, the National Cancer Policy Forum continued the conversation with two implementation-oriented workshops that resulted in publications called Implementing a National Cancer Clinical Trials System for the 21st Century (IOM, 2011b, 2013b)
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The purpose of the checklist was to determine the readiness of an omics test for use in guiding patient care in clinical trials.32 Advancing Cancer Prevention and Screening In addition to its work to support progress in cancer clinical trials and biomedical research broadly, the IOM also contributed to research related to the prevention, screening, and diagnosis of cancer (see related reports in Box 4-6)
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In 2010, the IOM released a report called Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C, which reviewed opportunities to prevent chronic liver disease and liver cancer. The committee, chaired by external volunteer R
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Like the IOM's 2003 report Fulfilling the Potential of Cancer Prevention and Early Detection, this new report outlined a national strategy focused on screening and prevention. Following a review of available evidence, the committee offered recommendations to improve surveillance, increase knowledge and awareness, expand rates of hepatitis B vaccination for at-risk populations, and strengthen programs for screening for, preventing, and controlling hepatitis B and C infections (IOM, 2010b)
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In 2003, the IOM released Responsible Research: A Systems Approach to Protecting Research Participants. The report was commissioned by HHS in response to public concern that originated from isolated but widely reported incidents involving research participants, such as the death of a volunteer in an asthma study.
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Sanford Schwartz after his passing, also in 2021. 39 "Impact of IOM Reports and Activities, Documented April–June 2014," in IOM Council Minutes, July 1, 2014; "Inspiring Action," IOM Council Minutes, April 15, 2015,
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Although the FDA had sponsored IOM reports previously, the IOM's relationship with the FDA solidified in the beginning of the 21st century when the IOM was called on to provide an unbiased assessment of the FDA's regulation of drugs following a turbulent period in the history of pharmaceutical policy and drug safety. In the last two decades of the 20th century, the FDA faced sharp political and public criticism over the slow speed of its drug approval process.
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The committee's first public meeting included testimony from Janet Woodcock, Deputy Commissioner of Operations at the FDA, who told the committee that the system had "obviously broken down to some extent." Woodcock cautioned, however, that risk-free drugs were not possible. "One of the questions on the table, really," she said, "is how much uncertainty are we willing to tolerate."42 On September 22, 2006, the IOM released the committee's much anticipated report, The Future of Drug Safety: Promoting and Protecting the Health of the Public.
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. Following the transition from the IOM to HMD, the forum established four thematic priorities to guide its activities: innovation and reform of the drug discovery and development enterprise, science across the drug development and discovery lifecycle, clinical trials and clinical product development, and infrastructure and workforce (NASEM, 2019i)
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In 1994, the VA asked the IOM to assess the feasibility of conducting epidemiological studies to evaluate possible effects in the spouses, children, and grandchildren of the atomic veterans. The challenge with diseases caused by radiation was that they were "generally indistinguishable from those that occur naturally in the population from other causes." In 1995, the IOM released Adverse Reproductive Outcomes in Families of Atomic Veterans: The Feasibility of Epidemiologic Studies, which was authored by a committee chaired by external volunteer William J
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. The IOM released Veterans at Risk: The Health Effects of Mustard Gas and Lewisite on January 6, 1993.
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• Veterans and Agent Orange: Update 2008 (2009) • Veterans and Agent Orange: Update 2006 (2007)
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Upon returning home, some of the veterans reported health concerns that they attributed to their military service and exposures during that time. As public scrutiny increased and symptoms were documented in 25 to 35 percent of veterans who served (IOM, 2013d)
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• Gulf War and Health: Volume 7: Long-Term Consequences of Traumatic Brain Injury (2009) • Gulf War and Health: Updated Literature Review of Depleted Uranium (2008)
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On two separate occasions, the VA asked the IOM and then the HMD to conduct studies related to the burn pits. In 2011, the IOM released Long-Term Health Consequences of Exposure to Burn Pits in Iraq and Afghanistan, which concluded that there was insufficient evidence available to provide concrete conclusions regarding the long-term health effects of burn pit exposure.
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, which supports its vision for "safer, healthier workers." In 2005, NIOSH provided support for the IOM to establish the Standing Committee on Personal Protective Equipment (PPE) for Workplace Safety and Health, which was designed "to provide strategic guidance in addressing PPE issues for a wide range of workers" (NASEM, 2019g, p.
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• The Health Hazard Evaluation Program at NIOSH: Reviews of Research Programs of the Na tional Institute for Occupational Safety and Health (2009) • Evaluating Occupational Health and Safety Research Programs: Framework and Next Steps (2009)
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. For example, in 2008, the IOM released a letter BOX 4-10 A Sample of Reports Commissioned to Advise the National Aeronautics and Space Administration • Review of NASA's Evidence Reports on Human Health Risks: 2017 Letter Report (2018)
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For example, in 1987 the IOM released its first report commissioned by SSA: Pain and Disability: Clinical, Behavioral, and Public Policy Perspectives. In its report, the committee -- chaired by NAM member Arthur Kleinman57 -- reviewed available evidence on pain and described how the SSA could evaluate claims related to chronic pain (IOM, 1987)
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• The Dynamics of Disability: Measuring and Monitoring Disability for Social Security Programs (2002) BUILDING CAPACITY OF INTERNATIONAL SCIENCE ACADEMIES The IOM also serves as an advisor to peer organizations around the globe, with the African Science Academy Development Initiative (ASADI)
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In September 2009, the Board on African Science Academy Development, working in collaboration with the Network of African Science Academies, hosted a week-long training program in Washington, DC, for 23 African program and research staff. The participants engaged in sessions on how the IOM conducts its work and develops evidencebased recommendations in the United States, as well as discussions of the various models of convening activities the IOM uses, such as forums, roundtables, and consensus studies, to fulfill its mission as advisor to the nation.59 CONCLUSION Improvements in human health -- from disease prevention to cure -- depend on advances in biomedical research and the translation of research findings into clinical and public health policy and practice.
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