Does a new medicine or diagnostic test work? Is it safe? Should the government approve it and insurers pay for it? The answers are not as straightforward as they may seem - and the reasons are the subject of a new book by Karen J. Maschke, a research scholar at The Hastings Center, and Michael K. Gusmano, a Hastings Center research scholar and an associate professor of health policy at Rutgers University School of Public Health.
Debating Modern Medical Technologies: The Politics of Safety, Effectiveness, and Patient Access, published by Praeger, delves into policy fights about what counts as evidence that new drugs and medical technologies are safe and effective. It uses five case studies to illustrate how such disputes play out.
- --Mammography: This case illustrates the concern about overdiagnosis and explores the debate about the value of mammography screening, especially to women under age 50.
--Brain imaging to detect signs of Alzheimer's disease: The second case explores the decision by the Centers for Medicare and Medicaid Services (CMS) not to pay for certain Medicare beneficiaries to undergo a PET scan that detects amyloid-beta plaque in the living brain. Even though the Food and Drug Administration (FDA) approved the PET scan for use in the clinic, CMS found insufficient evidence that test results would change the course of treatment or improve patient outcomes.
--Expensive hepatitis C treatments: The third case analyzes the criteria for deciding whether to pay for expensive new treatments for hepatitis C, initially costing nearly $100,000 per treatment. Public and private insurers have sought to limit coverage of these drugs, despite evidence that they are effective.
--FDA withdrawal of Avastin for breast cancer: In 2010, the FDA revoked its approval of Avastin, a drug for metastatic breast cancer, when postmarketing studies showed that it had limited effectiveness and serious side effects. The Avastin case raises questions about how to balance demands for faster access to drugs with concerns about safety and effectiveness. It also highlights the potential consequences of the failure to demand the timely completion of postmarketing studies by drug companies.
--Regulation of stem cell therapies: The final case focuses on the debate about whether the FDA has the authority to regulate stem cell and other regenerative medicine interventions. Some argue that they fall outside the FDA's purview and thus should not be subject to the agency's requirements for evidence of their safety and effectiveness.
"The fight over medical technology is not simply a story of powerful economic interests versus the public interest - it is often a fight among competing interests about the meaning of the public interest," the authors write. "The fight between those who emphasize the need for better evidence about the value of medical technologies and those who wish to expand their availability to patients are reflected in each of the cases we present in this book and involve a complex interplay of ideas about science and politics and material interests."
The book has received praise from leaders in medicine and health policy.
"This book should be required reading for every journalist writing about health policy, every student studying it, and every congressional and executive branch staffer/public official involved in making it." - Alice Sardell, Queens College, CUNY, and Author of Insuring Children's Health: Contentious Politics and Public Policy
"The book is a gold mine for all serious students--and practitioners--of health care policy." - Lawrence D. Brown, Professor of Health Policy, Department of Health Policy and Management, Columbia University, Mailman School of Public Health
"Debating Modern Medical Technologies is a timely and important book. As medical expertise and populism collide in the 'right to try movement' and unprecedented deregulation upends historic norms, stakeholders need an unbiased account of how decisions about medical technology are actually made." - Joseph J. Fins, MD, MACP, FRCP, Weill Cornell Medical College and Yale Law School and author of Rights Come to Mind: Brain Injury, Ethics and the Struggle for Consciousness