What Evidence is Essential for New Medical Products?
Implications for Patients and Health Policy
June 13, 2014
Jerry Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. An internist and drug epidemiologist, he studies the intended and adverse effects of prescription drugs, physician prescribing practices, and medication policy. The division he founded and leads comprises physicians, epidemiologists, health policy analysts, statisticians, and computer scientists who work together to analyze patterns of utilization and outcomes of prescription drugs in numerous settings. Dr. Avorn pioneered the “academic detailing” approach to continuing medical education, in which non-commercial, evidence-based information about drugs is provided to doctors through educational outreach programs run by public-sector sponsors. Such programs are now in use in the U.S., Canada, Australia, and Europe. Dr. Avorn did his undergraduate work at Columbia University in 1969, received the M.D. from Harvard Medical School in 1974, and completed a residency in internal medicine at the Beth Israel Hospital in Boston. He has served as a member of the Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice Guidelines and is the author or co-author of over 400 papers in the medical literature on medication use and its outcomes, and of the book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, now in its 11th printing.
Robert Ball, M.D., M.P.H, Sc.M.
Office of Surveillance and Epidemiology, FDA
Robert Ball is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for planning, managing, and directing the work of OSE staff evaluating drug risks and promoting the safe use of drugs by the American people. From 2008 to 2013, Dr. Ball served as the Director, Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER), FDA. In this role, Dr. Ball provided overall leadership and scientific direction to OBE and served as the principal advisor to the CBER director on all matters pertaining to statistical and epidemiological evaluation of regulated biological products. Dr. Ball led CBER post-marketing safety programs for vaccines and blood in the FDA’s Sentinel Initiative and with the Centers for Medicare and Medicaid Services. Dr. Ball began his FDA career in 1998 as a medical epidemiologist and was Chief, Vaccine Safety Branch, CBER from 2001 to 2007 where he oversaw the pharmacovigilance planning and evaluation of post-marketing safety for all vaccines licensed in the US. Dr. Ball received his BS in Mathematics and MD from Georgetown University, where he was elected to the Alpha Omega Alpha Honor Medical Society. He interned at the US Naval Hospital Bethesda, completed his MPH and residency in Occupational Medicine at the Uniformed Services University of the Health Sciences, and received the ScM degree in Infectious Disease Epidemiology and Vaccine Science and Policy from Johns Hopkins School of Public Health. Prior to joining the FDA, Dr. Ball served as a US Navy Medical Officer.
Gregory Curfman’s career as a professional medical editor at the New England Journal of Medicine spans 27 years. He is currently the executive editor of the Journal, a position that he has held for 13 years. Prior to being appointed executive editor, he served as deputy editor of the Journal for 14 years. The New England Journal of Medicine is an international medical journal that has been published continuously for over 200 years. Dr. Curfman is a board-certified internal medicine physician and cardiologist, and he holds two academic appointments at Harvard Medical School: assistant professor in the Department of Medicine and lecturer in the Department of Health Care Policy. He graduated magna cum laude from Princeton University, and cum laude from Harvard Medical School. He joined the editorial staff of the New England Journal of Medicine in 1986, where he now serves as the principal editor for cardiovascular disease. He also has a longstanding interest in health policy, and he founded and directs the Perspective section of the Journal. Dr. Curfman has authored 60 editorials and Perspective articles for the New England Journal of Medicine on a variety of topics in medicine and health care, including health policy, health law, and the regulation of drugs and medical devices.
Congresswoman Rosa DeLauro (D-CT)
Rosa DeLauro represents Connecticut’s Third Congressional District, which stretches from the Long Island Sound and New Haven to the Naugatuck Valley and Waterbury. Rosa serves in the Democratic leadership as co-chair of the Steering and Policy Committee, and she is the ranking member on the Labor, Health, Human Services, and Education Appropriations Subcommittee, where she oversees our country’s investments in education, health, and employment. From that position, Rosa works to increase support for education and innovation, to fully implement the Affordable Care Act, to protect the rights of employees and unions, and raise living standards. She also serves on the subcommittee responsible for funding the FDA and Agriculture Department, where she oversees drug and food safety. Rosa has long been a champion for drug and device safety to improve health and wellness, and has fought to ensure that women and minorities are represented and analyzed in clinical trial research. She has also led the fight in Congress to achieve full pay equity for women, and to ensure that all employees have access to paid sick days and family leave. Soon after earning degrees from Marymount College and Columbia University, Rosa followed her parents’ footsteps into public service, serving as the first Executive Director of EMILY’S List, a national organization dedicated to increasing the number of women in elected office, Executive Director of Countdown ’87, the national campaign that successfully stopped U.S. military aid to the Nicaraguan Contras, and as Chief of Staff to U.S. Senator Christopher Dodd. In 1990, Rosa was elected to the House of Representatives, and she has served as the Congresswoman from Connecticut’s 3rd District since.
Mark Frankel is director of the Scientific Responsibility, Human Rights and Law Program at the American Association for the Advancement of Science (AAAS), the largest multidisciplinary scientific society in the world. There he develops and manages AAAS’s activities related to the ethical, human rights, and legal aspects of science and technology. At AAAS, he has directed projects on research integrity and scientific misconduct; advocacy in science; personalized medicine; mobile health, and the implications of advances in neuroscience research for the legal system. Since 2006, he has organized nearly 20 seminars for federal and state judges on how advances in neuroscience may affect the courts. Dr. Frankel is a former member of the Boards of Directors of the National Patient Safety Foundation and the Food and Drug Law Institute and currently sits on the Board of the Center for Law, Science and Innovation at Arizona State University and the International Neuroethics Society. He serves on the editorial boards of Science and Engineering Ethics and the Journal of Empirical Research on Human Research Ethics. He is a Fellow of AAAS.
Curt Furberg received his medical training and a Ph.D.-equivalent at the University of Umea, Sweden. From 1974 through 1985 he was employed at the National Heart, Lung, and Blood Institute in Bethesda, MD. In 1986 he was appointed Director of the Center for Prevention Research and Biometry at Wake Forest University School of Medicine in Winston-Salem, NC. In 1989 he became department chair. He is currently Professor Emeritus. He has four decades of experience in the areas of epidemiology and clinical trials. He is considered a national leader in these fields. As Project Officer or Principal Investigator he served on a large number of primarily cardiovascular trials that documented the efficacy and safety of various interventions that led to improvements in the care for millions of patients with coronary heart disease, heart failure, hypertension and other vascular conditions. He served as charter member of the U.S. FDA Drug Safety and Risk Management. He was recently invited to serve on the United States Medicare Evidence Development and Coverage Advisory Committee. He has published about 450 scientific articles and co-authored four books including Fundamentals of Clinical Trials.
C. Bernie Good is an internist and faculty member of the Center for Health Equity Research and Promotion at the VA Pittsburgh Healthcare System; he is a Professor of Medicine and Pharmacy at the University of Pittsburgh. Dr. Good serves numerous national roles with the Department of Veterans Affairs, including serving as the chair of the Medical Advisory Panel for Pharmacy Benefits Management, and Co-Director for the VA Center for Medication Safety. As a recognized expert in drug safety and formulary management, Dr. Good is a member of the FDA Drug Oversight Board, and the Vice-chair of the Therapeutic Information and Formulary Support Expert Committee, United States Pharmacopeia (USP). Dr. Good has helped establish a medical clinic in Honduras, and takes medical students and pharmacy students to care for underserved patients there each year.
Margaret A. Hamburg is Commissioner of the Food and Drug Administration (FDA), where she has served since May 2009. As FDA Commissioner, she is advancing regulatory science, medical product innovation and globalization of the agency, while overseeing the implementation of groundbreaking laws to curb the use of tobacco and enhance food safety. She has undertaken major efforts to streamline and modernize FDA’s regulatory pathways. Before joining FDA, Dr. Hamburg was vice president and senior scientist at the Nuclear Threat Initiative. In the 1990s, as New York City’s Health Commissioner, she launched several major initiatives, including the nation’s first public health bioterrorism preparedness program and an internationally recognized program to curtail the resurgence and spread of TB. President Clinton later named her Assistant Secretary for Planning and Evaluation in the U.S. Department of Health and Human Services. Dr. Hamburg earned her M.D. from Harvard Medical School.
Louis Jacques is Chief Clinical Officer and a Senior Vice President at ADVI, where he is also a partner. ADVI is a health care advisory services firm with offices in Washington DC, Austin, and San Francisco. Before joining ADVI in 2014, Dr. Jacques was the Director of the Coverage and Analysis Group (CAG) in the Centers for Medicare & Medicaid Services (CMS) from 2009 – 2014, where he managed Medicare fee for service coverage policy development on technologies as diverse as molecular diagnostic testing, advanced imaging, chemotherapeutics, wound care, and screening and preventive services. From 2004 – 2009 he was a division director within CAG. Before joining CMS in 2003, he served as the Associate Dean for Curriculum at Georgetown University School of Medicine; where he also saw patients at the Lombardi Cancer Center in his practice of hospice and palliative medicine. Jacques also made volunteer home visits for a hospice on Maryland’s Eastern Shore. While in active clinical practice he was a diplomate of both the American Board of Hospice and Palliative Medicine and the American Board of Family Medicine. He recertified his Family Medicine boards in 2013. Louis earned his undergraduate degree in 1978 from Georgetown University and his MD in 1982 from the University of Maryland. After completing his residency in family practice he served in a National Health Service Corps assignment in a Waterloo Iowa community health clinic. Before returning to the Washington DC area he worked in Detroit with the Henry Ford Medical Group and joined the faculty of the Wayne State University School of Medicine.
Aaron S. Kesselheim is an Assistant Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital (BWH). His research focuses on the effects of intellectual property laws and regulatory policies on pharmaceutical development, the drug approval process, and the costs, availability, and use of prescription drugs both domestically and in resource-poor settings. Dr. Kesselheim leads the Program On Regulation, Therapeutics, And Law, an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. In 2013, Dr. Kesselheim was named a Greenwall Faculty Scholar in Bioethics by the Greenwall Foundation, which supports innovative empirical research in bioethics. Dr. Kesselheim’s work is also currently funded by the Agency for Healthcare Research and Quality, the FDA, and by a Robert Wood Johnson Investigator Award in Health Policy Research. He has testified before Congress on pharmaceutical policy and medical device regulation, and served as a consultant for the NIH, FDA, Institute of Medicine, USPTO, and numerous state government offices. He is Board Certified in Internal Medicine, and serves as a primary care physician at the Phyllis Jen Center for Primary Care at BWH.
Tianjing Li is Assistant Professor in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. Dr. Li holds advanced degrees in medicine, epidemiology, and biostatistics. Dr. Li’s main areas of research include the methodology of meta-analysis, network meta-analysis, systematic review, clinical trial, missing data, reporting bias, and developing and prioritizing comparative effectiveness research. Dr. Li has conducted and published many systematic reviews and meta-analyses, and has led several priority setting projects funded by the Cochrane Collaboration, the National Eye Institute, and the Patient Centered Outcomes Research Institute (PCORI). Dr. Li co-convenes the Cochrane Collaboration’s Methods Group for Comparing Multiple Interventions, an international group that innovates methodological and statistical approaches for conducting network meta-analysis. Dr. Li also co-convenes the Cochrane Agenda and Priority Setting Methods group. Dr. Li received funding from PCORI to identify and recommend standards for preventing and handling missing data, which resulted in a chapter in the PCORI Methods Guide and a publication in the Journal of Clinical Epidemiology. Dr. Li serves as an Associate Editor for Ophthalmology and oversees all systematic review submissions made to the journal. Dr. Li has special experience with US-based regulatory science and clinical trials. She serves a co-investigator on a FDA- and PCORI- funded project to develop global sensitivity analysis approach for missing data. She served as the Associate Director of the Coordinating Center for an NIH-funded randomized controlled trial. She is a core faculty member of the Center for Drug Safety & Effectiveness based in the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health. Dr. Li has taught in graduate level courses on systematic reviews, clinical trials, epidemiology, and biostatistics at the JHBSPH for the past several years.
Bernard Lo is President of the Greenwall Foundation, whose mission is supporting bioethics research and young researchers in bioethics. He is Professor Emeritus of Medicine and Director Emeritus of the Program in Medical Ethics at the University of California San Francisco (UCSF). A member of the Institute of Medicine (IOM), Dr. Lo served on the IOM Council and chaired the Board on Health Sciences Policy. He chaired an IOM committees on conflicts of interest in medicine and currently is chairing an IOM committee on responsible sharing of clinical trials data. Dr. Lo serves on the Board of Directors of Association for the Accreditation of Human Research Protection Programs and on the Medical Advisory Panel of Blue Cross/Blue Shield. Formerly he was a member of the National Bioethics Advisory Commission, the NIH Recombinant DNA Advisory Committee, and Ethics Subcommittee of the Centers for Disease Control and Prevention. Dr. Lo and his colleagues have published around 200 peer-reviewed articles on ethical issues concerning decision-making near the end-of-life, oversight of research, the doctor-patient relationship, and conflicts of interest. He is the author of Resolving Ethical Dilemmas: A Guide for Clinicians (5th ed., 2013) and of Ethical Issues in Clinical Research (2010). He continues to care for a panel of primary care internal medicine patients at UCSF.
Peter Lurie is Acting Associate Commissioner for Policy and Planning at the Food and Drug Administration, where he has worked on a number of policy issues, including antimicrobial resistance, drug shortages, prescription drug abuse and the international dimensions of tobacco control. Prior to that, he was Deputy Director of Public Citizen’s Health Research Group in Washington, DC, where he addressed a variety of FDA regulatory policies, a number of specific drug and device issues, efforts to reduce worker exposure to hexavalent chromium and beryllium and excessive medical resident work hours. He had an earlier academic career at the University of California, San Francisco and the University of Michigan in which he studied needle exchange programs, ethical aspects of mother-to-infant HIV transmission studies and the economic and public health aspects of a number of HIV policies domestically and abroad.
Rita F. Redberg has been a cardiologist and Professor of Medicine at the University of California, San Francisco since 1990. Dr. Redberg is currently the Chief Editor of JAMA Internal Medicine (formerly Archives of ) and has spearheaded the journal’s new focus on health care reform and “less is more”, which highlights areas of health care with no known benefit and definite risks. Her research interests are in the area of health policy and technology assessment focusing, insurance coverage and medical guidelines and practice, particularly in the area of medical devices and comparative effectiveness of methods of diagnosis of coronary artery disease. Dr. Redberg is a member of the Medicare Payment Advisory Commission. She also served on the Medicare Evidence, Development and Coverage Advisory Committee from 2003-2006 and was reappointed in 2012 as Chair of MEDCAC. Dr Redberg is a member of the California Technology Assessment Forum, the Medical Policy Technology and Advisory Committee, and the Food and Drug Administration Cardiovascular Devices Expert Panel, and is a consultant for the Center for Medical Technology Policy. She gave Congressional testimony four times in 2011 in hearings related to the issue of balancing safety and innovation in medical device approvals. Dr. Redberg worked in the office of Senator Hatch and with the Senate Judiciary Committee on FDA-related matters during her tenure as a Robert Wood Johnson Health Policy Fellow, 2003-2006. Dr. Redberg was a member of the Institute of Medicine’s Learning Health Care Committee. She chaired the AHA/ACC Writing Group on Primary Prevention Performance Measures and is a member of the American College of Cardiology’s (ACC) Clinical Quality Committee and serves on the Quality in Technology Work Group. She does extensive comparative effectiveness research, and serves on the American College of Cardiology’s Comparative Effectiveness Work Group, and serves on multiple other ACC Committees, including several on appropriate use of cardiac imaging. She is on the Institute of Clinical and Economic Review Advisory Board, a comparative effectiveness organization. Dr. Redberg graduated from Cornell University and the University of Pennsylvania Medical School and has a Master of Science in Health Policy and Administration from the London School of Economics.
Michael Rosenblatt is executive vice president and chief medical officer at Merck. He is the company’s primary external advocate on medical issues and represents the voice of the patient inside Merck. Dr. Rosenblatt previously was Dean of Tufts University School of Medicine; the George R. Minot Professor of Medicine at Harvard Medical School; and president of Beth Israel Deaconess Medical Center (BIDMC). He was the Harvard faculty dean and senior vice president for academic programs at BIDMC. He was also director of the Harvard-MIT Division of Health Sciences and Technology. Prior to these leadership positions, he was senior vice president for research at Merck where he co-led the worldwide development team for alendronate (FOSAMAX®). Earlier, he was chief of the Endocrine Unit at the Massachusetts General Hospital. He has served on the board of directors and scientific advisory boards of several biotechnology companies and is a scientific founder of ProScript, Radius Pharmaceuticals and Theracrine. Dr. Rosenblatt was elected to the American Society of Clinical Investigation and the Association of American Physicians, is a fellow of the American Association for the Advancement of Science and the American College of Physicians, and served as the president of the American Society of Bone and Mineral Research. He received his undergraduate degree from Columbia University and his M.D. from Harvard Medical School.
Joseph S. Ross is an Assistant Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management) at the Yale University School of Medicine, a member of the Center for Outcomes Research and Evaluation at the Yale-New Haven Hospital, and an Assistant Director of the Robert Wood Johnson Foundation’s Clinical Scholars program at Yale. He is an expert at performance measure development and on the translation of clinical research into practice, using health policy research methods to examine the use and delivery of higher quality care and to better understand issues related to pharmaceutical and medical device evidence development and post-market surveillance. Dr. Ross has published more than 130 articles in peer-reviewed journals and is currently an Associate Editor at JAMA Internal Medicine.
Patrick Ryan is the Head of Epidemiology Analytics at Janssen Research and Development, where he has leading efforts to develop and apply analysis methods to better understand the real-world effects of medical products. He is currently a collaborator in Observational Health Data Sciences and Informatics, a multi-stakeholder, interdisciplinary collaborative to create open-source solutions that bring out the value of observational health data through large-scale analytics. He served as a principal investigator of the Observational Medical Outcomes Partnership, a public-private partnership chaired by the Food and Drug Administration, where he led methodological research to assess the appropriate use of observational health care data to identify and evaluate drug safety issues. Patrick received his undergraduate degrees in Computer Science and Operations Research at Cornell University, his Master of Engineering in Operations Research and Industrial Engineering at Cornell, and his Ph.D. in Pharmaceutical Outcomes and Policy from University of North Carolina at Chapel Hill. Patrick has worked in various positions within the pharmaceutical industry at Pfizer and GlaxoSmithKline, and also in academia at the University of Arizona Arthritis Center.
Sebastian Schneeweiss is Professor of Medicine and Epidemiology at Harvard Medical School and Vice Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics of the Dept. of Medicine, Brigham and Women’s Hospital. He is Principal Investigator of the Harvard-Brigham Drug Safety Research Center funded by FDA/CDER, and Methods Lead of the FDA Mini Sentinel program. His research is funded by multiple grants from NIH, PCORI and FDA and focuses on the comparative effectiveness and safety of biopharmaceuticals and analytic methods to improve the validity of epidemiologic studies using complex healthcare databases particularly for newly marketed medical products. His work is published in high-ranking journals and was featured in Discover Magazine. Dr. Schneeweiss is Past President of the International Society for Pharmacoepidemiology and is Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology. He is voting consultant to the FDA Drug Safety and Risk Management Advisory Committee and member of the Methods Committee of the Patient Centered Outcomes Research Institute. He received his medical training at the University of Munich Medical School and his doctoral degree in Pharmacoepidemiology from Harvard.
Lisa Schwartz is Professor of Medicine and Community and Family Medicine at Dartmouth Medical School and co-Director of the Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice. Together with Dr. Steven Woloshin, she has worked to improve communication of medical evidence to physicians, journalists and the public. Her areas of expertise include risk communication (medical statistics, screening), prescription drugs (FDA policy and evidence, direct-to-consumer advertising), medicine and the media, and overdiagnosis. Her current focus is on communicating the benefits, harms and uncertainties of prescriptions drugs using a template she developed, the Drug Facts Box (included as Section 3507 in the Affordable Care Act). In collaboration with the NIH, she co-directs an annual symposium for health journalists called “Medicine and the Media: Reporting on Medical Research.” She is a co-author of two books: Know Your Chances and Overdiagnosed, an occasional columnist for the British Medical Journal, and her essays have appeared in the New York Times, Washington Post and Los Angeles Times.
Joe V. Selby is the first Executive Director of the Patient-Centered Outcomes Research Institute (PCORI). A family physician, clinical epidemiologist and health services researcher, he has dedicated his career to patient care, clinical research and administration. At PCORI, he works to identify and address strategic issues and opportunities for PCORI and to implement and administer the research agenda authorized by the PCORI Board of Governors. Building on the foundational work of the Board, Selby leads the continuing development of PCORI as a research organization, overseeing the implementation of its research agenda, its external communications, and its work to establish effective on-going, two-way engagement channels with each of PCORI’s key stakeholder groups, beginning with patients. Selby joined PCORI from Kaiser Permanente, Northern California, where he was a researcher for 27 years, serving as Director of the Division of Research for the last 13 years. In this role, he led a department of more than 50 investigators and 500 research staff working on more than 250 ongoing studies. An accomplished researcher, Selby has authored more than 220 peer-reviewed articles, primarily in the areas of primary care delivery; diabetes mellitus outcomes and quality improvement; colorectal cancer screening strategies; population management for chronic conditions; and quality measurement. Selby was elected to membership in the Institute of Medicine in 2009. A native of Fulton, Missouri, Selby received his medical degree from Northwestern University; his training in family medicine from Contra Costa County Family Medicine Program, Martinez, CA, and his master’s in public health from the University of California, Berkeley. He served as a commissioned officer in the Public Health Service with the National Health Services Corp from 1976-1983 and received the Commissioned Officer’s Award in 1981. Dr. Selby was appointed PCORI executive director on May 16, 2011.
Anne Trontell is the Senior Advisor on Pharmaceutical Outcomes and Risk Management in the Agency for Healthcare Research and Quality’s (AHRQ) Center for Outcomes and Evidence, where she is the Program Director for the Centers for Education and Research on Therapeutics (CERTs) Program, a longstanding research network of 7 centers working on individual and collaborative projects to optimize the use of drugs, devices, and biological products. She contributes to multiple Effective Health Care Program activities, the most recent and significant being her leadership of the $120 million CHOICE portfolio of large-scale, rapid-cycle pragmatic/prospective clinical studies in comparative effectiveness. Dr. Trontell represents AHRQ on the Clinical Trials Transformation Initiative, the Federal Working Group for the FDA mini-Sentinel Initiative, and the FDA Drug Safety Board. A pediatrician and epidemiologist, Dr. Trontell has expertise in FDA drug review and safety assessments, risk communication, and risk management based on 9 years of experience and leadership within FDA’s Center for Drug Evaluation and Research. Prior to FDA, she was Chief Scientist at the Health Care Financing Administration (HCFA) Office of Research and Demonstrations, where she helped lead outcomes research and public campaigns to promote preventive services use by Medicare beneficiaries. Dr. Trontell was an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention and ran a small contract research group doing environmental safety and health consulting prior to her medical and public health training at Boston’s Children’s Hospital, the University of Pennsylvania, and the Harvard School of Public Health. She serves as a Captain in the US Public Health Service Commissioned Corps.
Ann de Velasco has been a registered nurse since 1967. Her career has consisted of opportunities in nephrology, clinical research and cardiology. She was nurse manager of the first hemodialysis/ kidney transplant unit at her county teaching hospital, was owner and administrator of independent dialysis facilities, worked in the first coronary care unit in Miami, and served as a patient recruiter for NIH clinical trials. In June of 2000, she experienced a heart attack which markedly changed her life and my career focus. After attending cardiac rehabilitation, she joined the staff at Miami Cardiac and Vascular Institute, a founding member of the WomenHeart National Hospital Alliance. She remains employed there as a patient educator and cardiac rehab nurse. In 2003, she attended the WomenHeart Science and Leadership Symposium at the Mayo Clinic and became a WomenHeart Champion. She began the WomenHeart of Miami Support Network upon her return, and for the past 10 years has conducted monthly meetings for women with heart disease. She participates in outreach activities for the English and Hispanic communities on a regular basis as part of her WomenHeart role, and serves as a speaker for related events across the country and for the first time this year, in Puerto Rico. In 2009, she was elected to the Board of Directors of WomenHeart. Her passion remains to support and educate women about heart disease, the number one cause of death in women. As a survivor, cardiac nurse, and WomenHeart Champion, she welcomes every opportunity to be the voice of her Heartsisters everywhere.
Kim Witczak is an advocate for patient safety and co-founder of the patient nonprofit organization Woody Matters. She became involved in pharmaceutical drug safety issues after the death of her husband, Tim “Woody” Witczak in 2003 as a result of an undisclosed drug side effect. In 2004, Kim launched www.woodymatters.com in memory of Woody’s life and death, as a resource for other patients and family members. An advertising/marketing and communication consultant, Kim’s advocacy has included a public awareness campaign aimed at persuading the FDA to include a black box warning about the suicide risk of SSRI antidepressants (which the FDA eventually included). Kim has testified before the U.S. Senate on FDA reform as well as numerous FDA Advisory Committees. In 2008 she was appointed to the FDA’s Psychopharmacologic Drugs Advisory Committee as a Patient Representative. She has also been actively involved in Consumer Reports’ Safe Patient Project.
Steven Woloshin is Professor of Medicine and Community and Family Medicine at Dartmouth Medical School and co-Director of the Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice. Together with Dr. Lisa Schwartz, he has worked to improve communication of medical evidence to physicians, journalists and the public. His areas of expertise include risk communication (medical statistics, screening), prescription drugs (FDA policy and evidence, direct-to-consumer advertising), medicine and the media, and over diagnosis. His current focus is on communicating the benefits, harms and uncertainties of prescriptions drugs using a template he developed, the Drug Facts Box (included as Section 3507 in the Affordable Care Act). In collaboration with the NIH, he co-directs an annual symposium for health journalists called “Medicine and the Media: Reporting on Medical Research.” He is a co-author of 2 books: Know Your Chances and Overdiagnosed, an occasional columnist for the British Medical Journal, and his essays have appeared in the New York Times, Washington Post and Los Angeles Times.
Dr. Robert Yarchoan conducts research on HIV and associated tumors as a Principal Investigator in the National Cancer Institute (NCI) and also coordinates HIV/AIDS research throughout the NCI as Director of the Office of HIV and AIDS Malignancy. He played a major role in the development of the first effective therapies for HIV infection, including zidovudine (AZT), didanosine (ddI), and zalcitabine (ddC). He led the first clinical trials of these drugs, was a co-inventor of didanosine and zalcitabine, and led initial studies of combination anti-HIV therapy. His research is now focused on AIDS-related malignancies, especially tumors caused by Kaposi’s sarcoma-associated herpesvirus (KSHV). He has recently shown that KSHV-associated multicentric Castleman disease can be treated through the use of drugs activated by KSHV to toxic moieties; this represents one of the first anti-tumor therapies targeting a causative oncogenic virus. Dr. Yarchoan received his B.A. from Amherst College and his M.D. from the University of Pennsylvania. He trained in internal medicine at the University of Minnesota and immunology in the Metabolism Branch, NCI, and then worked for several years in the laboratory of Dr. Samuel Broder, where he initiated his research developing drugs for AIDS. He was a Section Chief in the NCI Medicine Branch from 1991 to 1996 and was named chief of the newly formed HIV and AIDS Malignancy Branch in 1996, a position he still holds. In December 2007, Dr. Yarchoan was appointed as the first Director of OHAM. Among other honors, he has been awarded the Assistant Secretary for Health Award and the U.S. Public Health Service Outstanding Service Medal, has been inducted as a Fellow of the American Association for the Advancement of Science, and is a member of the American Society for Clinical Investigation. In December 2006, he was a recipient of the first NIH World AIDS Day Award, and in November 2007 he received the NCI HIV/AIDS Research Excellence Award. In 2013 he received an honorary degree from Amherst College, and in 2014 was the recipient of the American Society for Microbiology Abbott Award for Diagnostic and Clinical Immunology.
Diana Zuckerman is the President of the National Center for Health Research, a nonprofit research and education organization that works to improve policies and programs that affect the health of adults and children. In 2007, she founded the Center’s Cancer Prevention and Treatment Fund. She has testified about the safety and efficacy of medical devices and drugs several dozen times before Congress and the FDA, and has also testified before several state legislative committees and the Health Committee of the Canadian Parliament. Her research on high-risk recalls of medical devices resulted in several hearings in the U.S. Senate and U.S. House of Representatives. After starting her career as a faculty member at Vassar and Yale and a research director at Harvard, Dr. Zuckerman came to Capitol Hill as a AAAS Congressional Science Fellow. She worked for a dozen years as a Congressional staffer on health policy issues in the House Government Operations Committee (now Oversight and Government Reform) and the Senate Committee on Veterans Affairs. She then served as a senior policy advisor in the Clinton White House. She has been president of the National Center for Health Research since 1999, and at the same time was a fellow at the University of Pennsylvania Center for Bioethics for seven years. In 2010, she was inducted as the first non-physician into the Women in Medicine International Hall of Fame. She previously chaired the Women’s Health Promotion Council for the State of Maryland and currently serves on the Medicare Coverage Advisory Committee and the Board of Directors of the Congressionally mandated Reagan-Udall Foundation and the Alliance for a Stronger FDA. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals and national newspapers. She has been interviewed on numerous TV and radio news programs and talk shows, and has been quoted in the major U.S. newspapers and news magazines.