Fact Squad on Prescription Drugs
According to a October 2005 Harris Poll, only nine percent of the American public considers the pharmaceutical industry generally honest and trustworthy.
If perception were reality, the prescription drug industry would be in Chapter 11. Whether it is anger at the callous disregard for human health revealed in the Vioxx and SSRI scandals; irritation with the incessant peddling of drugs directly to consumers and giveaways to doctors; ire at the frustration with the concealment of adverse clinical trial findings; exasperation that safe, cheap drugs are barred from importation from Canada; or disgust with conflicts of interest in the drug approval process and the buying of political influence, over 90 percent of the public views the drug industry with suspicion. A majority say they want more, not less, regulation. Indeed, industry sales are down this year and companies are laying off thousands of workers. But these selective factoids can be deceiving: Pfizer is among the companies cutting its workforce, while its profits for 2005 will be $8 billion. Hold your pity.
Not only do Americans not trust the industry, but there is a crisis of confidence in the FDA as an impartial arbiter of drug safety and effectiveness. The public understands that “He who pays the piper calls the tune.” More than half of the agency’s drug budget comes from industry user fees earmarked for speeding up the approval of drugs. As a result, the FDA, long established as the “gold standard” of consumer protection against industry’s dangerous drugs, now treats the industry as its primary client.
If we, the public, can’t rely on either industry or FDA to tell it to us straight, then where can we turn for independent and reliable information about prescription drugs?
GAP has set out to help fill this void with our own “Fact Squad” of experts, compiled with the guidance of award-winning investigative journalist Jeanne Lenzer. In commending this “Fact Squad” to the public and the news media, we ask that you take note of their backgrounds, education and accomplishments, and give due consideration to their perspectives. The pharmaceutical industry has a story to tell -- and a bottomless bank account with which to tell it -- but it is a self-interested story. Our “Fact Squad” will help complete the picture by bringing into focus the findings of experts whose first concern is the public interest.
Scroll down and review their credential and areas of expertise. GAP will be happy to put you in touch with them. Contact Food and Drug Safety Director Mark Cohen at markc@whistleblower.org or call Mark at (202) 408-0034 x128.
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The Fact Squad
Dr. John Abramson, MD
Dr. Abramson teaches primary care at Harvard Medical School. He has worked as a family doctor and has served as chairman of the department of family practice at Lahey Clinic. He was a Robert Wood Johnson fellow and is author of Overdosed America. He is an expert regarding commercial influences over medical research and medical knowledge, direct to consumer advertising, and the high cost and poor performance of the American health care system. Specific issues of interest include cox-II inhibitors, antidepressants, and Nexium, as well as the inappropriate focus on lowering cholesterol with statin drugs rather than promoting healthy lifestyle change to prevent heart disease.
Marcia Angell, M.D.
Dr. Angell was named by Time Magazine as one of the 25 most influential Americans in 1997. She is a senior lecturer in the Department of Social Medicine at Harvard Medical School. In 2000, she stepped down as Editor-in-Chief of the New England Journal of Medicine in 2000, where she had worked since 1979. Dr. Angell is the author of Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case, and The Truth About the Drug Companies: How They Deceive Us and What to Do About It. Writing frequently in professional journals, her areas of expertise include medical ethics, health policy, the nature of medical evidence, the interface of medicine and the law, care at the end of life, and the relations between industry and academic medicine.
David Antonuccio, Ph.D
David O. Antonuccio, Ph.D., is a professor in the Department of Psychiatry at the University of Nevada School of Medicine. A fellow of APA and an ABPP diplomate in clinical psychology, Dr. Antonuccio is internationally known for his work in depression and smoking cessation. His articles on the comparative effects of psychotherapy and pharmacotherapy have received extensive coverage by the national media and are models of careful scholarship. He is an expert in clinical psychology specializing in the treatment of depression, anxiety, sexual dysfunction, and smoking cessation.
Otis Brawley, M.D.
Dr. Brawley is Professor of Hematology, Oncology, and Medicine at the Emory University School of Medicine and Professor of Epidemiology at the Emory Rollins School of Public Health. He also serves as Associate Director of the Winship Cancer Institute at Emory University. In addition Dr. Brawley is Chief of Hematology and Oncology Services and the Medical Director of the Georgia Cancer Center for Excellence at Grady Health System. He has previously served as Assistant Director of the National Cancer Institute for the Office of Special Populations Research and was a Senior Investigator in the Division of Cancer Prevention and Control at the National Cancer Institute. He is the recipient of numerous awards to include the U.S. Surgeon General’s Medal and has been named a Georgia Cancer Coalition Eminent Scholar. Dr. Brawley’s research interests include the screening, epidemiology, diagnosis, prevention and treatment of hormonal cancer. He has additional interests in the design of clinical trials, inclusion of minorities in trials and the availability of state-of-the-art health care to the socio-economically disadvantaged.
Howard Brody, M.D., Ph.D.
Dr. Brody is a professor of family practice and in the Center for Ethics and Humanities in the Life Sciences, College of Human Medicine, Michigan State University. He served as the director of the Center from 1985-2000. He also is a professor of philosophy at MSU, maintains a part-time clinical practice, and teaches medical students and residents. He is a member of the Institute of Medicine and the National Academy of Sciences. Dr. Brody has authored numerous books including Stories of Sickness and The Healer’s Power. He is an expert in medical ethics and the relationship between medicine and the pharmaceutical industry.
Adriane Fugh-Berman, M.D.
Dr. Fugh-Berman is an Associate Professor in the Department of Physiology and Biophysics at Georgetown University Medical Center. She teaches in the Complementary and Alternative Medicine Master’s Program and is involved in research on the physiological effects of botanicals. She is the author of The 5-Minute Herb and Dietary Supplement Consult and many articles on women’s health, preventive medicine, and corporate influence on prescribing in both academic and consumer publications. Dr. Fugh-Berman’s current research interests include rational prescribing; the hidden influence of pharmaceutical companies on medical information provided to health care practitioners and consumers; and the medicalization of prevention.
Curt Furberg, M.D., Ph.D.
Dr. Curt Furberg is professor of Public Health Sciences at the Wake Forest University School of Medicine and serves as the senior advisor to the dean for Health Services Research and Health Policy. Previously, he worked at the National Heart, Lung and Blood Institute where he served as Chief, Clinical Trials Branch. Dr. Furberg is co-author of a leading text book on clinical trial methodology, Fundamentals of Clinical Trials. He is also co-author of a new text book, Data Monitoring in Clinical Trials: A Case Studies Approach, and has published more than 350 articles. Dr. Furberg is a well known cardiovascular epidemiologist with expertise in clinical trials, drug evaluation, drug safety and the pricing of drugs. He is a member of the FDA Advisory Committee on Drug Safety and Risk Management.
Merrill Goozner
Merrill Goozner is Director of the Integrity in Science Project at the Center for Science in the Public Interest. Mr. Goozner joined CSPI in December 2003 after a three-year stint teaching journalism at New York University and more than 20 years as a practicing journalist, primarily with the Chicago Tribune, where he served as Washington chief economics correspondent (1998-2000), New York financial correspondent (1996-1998), and chief Asia correspondent based in Tokyo (1991-1995). Having won numerous journalism awards, his work has appeared in major media outlets, and he is a contributing editor of The American Prospect. Mr. Goozner is an expert in drug development, conflicts of interest in medicine, and clinical trials, and he is a close follower of Medicare and Food and Drug Administration policies.
David Graham, M.D., M.P.H.
Dr. Graham is the associate director of the Office of Drug Safety at FDA. In his 20 years at FDA he has challenged the safety of 12 drugs, of which 10 were removed from the market, including Vioxx. He has received numerous awards including the Award for Excellence from the American Public Health Association, the Joe A Callaway Award for Civic Courage from the Shafeek Nader Trust for the Community Interest, and the Cliff Robertson Sentinel Award from the Association of Certified Fraud Examiners. Dr. Graham graduated from the John Hopkins University School of Medicine and did residencies at Yale and the University of Pennsylvania. He has expertise in epidemiology, the testing and review of drugs, and an extensive knowledge on the inner workings of FDA. Dr. Graham is a GAP client.
David Healy, M.D., FRCPsych
Dr. Healy is a professor of psychological medicine at Cardiff University of Wales in the UK. He is one of Europe’s eminent scientists and is renowned for his work with anti-depressant drugs. He has lectured around the world and has authored 13 books. His expertise includes Selective Seratonin Re-uptake Inhibitors, such as Prozac, and the fields of psychopharmacology and psychiatry.
David Himmelstein, M.D.
Dr. Himmelstein is an associate professor of medicine at Harvard Medical School. He practices primary care internal medicine and serves as chief of the Division of Social and Community Medicine at Cambridge Hospital in Cambridge, MA. He co-founded Physicians for a National Health Program (PNHP) and is the co-director of the Center for National Health Program Studies at The Cambridge Hospital and Harvard Medical School. He is an expert in health policy, access to health care, health care reform, and internal medicine.
Jerome Hoffman, M.D.
Dr. Hoffman is professor of medicine and emergency medicine at the University of California at Los Angeles School of Medicine. He is a health services researcher, who also served as director of the UCLA Doctoring Program for over 10 years. Dr. Hoffman is an expert in clinical epidemiology, critical appraisal (the technique of evaluating medical literature critically and appropriately to assist medical practice), and the influence of drug companies on physicians, health care entities (medical journals, universities, research organizations), and public policy.
John Jureidini, Ph.D., FRANZCP, M.B.B.S.
Dr. Jureidini is the head of the Department of Psychological Medicine at the Women and Children’s Hospital of Adelaide, South Australia. He is a clinical senior lecturer in the department of psychiatry at the University of Adelaide and a senior research fellow in the Department of Philosophy at Flinders University of South Australia. He is an expert in depression in children, ADHD, dissociation, and chronic illness in children.
Stefan P. Kruszewski, M.D.
Dr. Kruszewski is a graduate of Harvard Medical School and completed post-doctoral work at Harvard Affiliate Hospitals and Duke University. He has served as Clinical Professor of Psychiatry at Penn State College of Medicine and as Associate Medical Director of the Physicians’ Health Programs of the Foundation of the Pennsylvania Medical Society. He is certified in general psychiatry as well as geriatric, adolescent and addiction psychiatry and, by the American Society of Addiction Medicine, in addiction medicine. He is an expert in addictive diseases and the scientific basis that underscores certain neuropsychiatric drugs, including drugs of abuse, antipsychotics, anticonvulsants, mood stabilizers and stimulants.
Allen Shaughnessy, Pharm.D.
Dr. Shaughnessy is a board certified pharmacotherapy specialist and is a fellow of the American College of Clinical Pharmacy. He is an adjunct professor of public health and family medicine at Tufts University School of Medicine and teaches in the Tufts University Family Medicine Residency. He co-developed the concept of “Patient-Oriented Evidence that Matters,” which focuses on finding and evaluating information that directly affects the health and well-being of patients. Dr. Shaughnessy is an expert in evidence-based medicine, pharmacology, clinical information management by physicians, and the interaction between physicians and the pharmaceutical industry.
Leonore Tiefer, Ph.D.
Dr. Tiefer is a clinical psychologist and Clinical Associate Professor in Psychiatry at the New York University School of Medicine. She is internationally known as an expert in sexuality, the author or co-author of four books and scores of professional publications, has been elected to major professional offices, and holds editorial roles with the leading sexology journals. She received the Distinguished Lifetime Scientific Achievement award in 2004 from the Society for the Scientific Study of Sexuality. Dr. Tiefer served as a member of an FDA Advisory Committee on the "Uprima" application in 2000, and testified at the FDA Advisory Committee meeting on "Intrinsa" in 2004. Her expertise is in the area of sexuality and sexuopharmaceuticals.
Michael Wilkes, M.D., Ph.D.
Dr. Michael Wilkes is vice dean for medical education and a professor of medicine at the University of California at Davis. He is an award-winning teacher and has worked in a host of countries as a consultant in curriculum development. He is an NIH and CDC funded researcher studying the dissemination of information, physician practice behaviors, and use of new technology and pharmaceuticals. He is also the head of the Adolescent Medicine Unit at the University Hospital. He has testified in front of the House Government Reform Committee and has been a medical commentator on NPR for the past 15 years. He has expertise in drug policy, physician education, cancer screening, clinical epidemiology, general internal medicine, and adolescent medicine.
Steffie Woolhandler, M.D., M.P.H.
Dr. Woolhandler is an associate professor of medicine at Harvard Medical School and is co-director of the Harvard Medical School General Internal Medicine Fellowship Program. She practices primary care internal medicine at Cambridge City Hospital, and co-founded and is a board member of Physicians for a National Health Program (PNHP). She is an expert on administrative waste, health policy, access to health care, health care reform, and internal medicine.
Diana Zuckerman, Ph.D.
Dr. Zuckerman has been president of the National Research Center for Women & Families since it was founded in 1999. A post-doctoral fellow in epidemiology at Yale Medical School, a former faculty member at Vassar College and Yale, and the director of a longitudinal research project at Harvard, Dr. Zuckerman is the author of four books and numerous articles in medical and academic journals. She served for 11 years as a House and Senate staffer, where she was responsible for more than a dozen investigations and hearings on health issues, and then took a position as a senior policy advisor to the White House in 1995, working for the First Lady and the Office of Science and Technology Policy. Her areas of expertise include FDA, safety of prescription drugs and medical devices, conflicts of interest in medical research, and women’s health.
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