Inside Politics
OSHR-701.49
Allan Kleinman
Did you ever wonder how new and effective cures and therapies for devastating diseases are discovered and become part of standard medical practice? This lecture series will provide an overview of the process. We will focus on five topics: (1) observing a disease to develop hypotheses about the underlying disease mechanisms and possible treatments or cures; (2) designing biological experiments using laboratory animals to test hypotheses about disease mechanisms and cures; (3) carrying out human clinical trials to demonstrate safety and effectiveness and to obtain FDA approval for the new lab test, drug, or device; (4) overcoming obstacles in order to achieve an approved and reimbursable new standard of care for preventing and treating the disease; and (5) exploring the future of medicine with an eye to potential developments that look promising.
January 12: Generating Hypotheses
This class will discuss the leading causes of death and suffering; the CDC network for monitoring infectious diseases; the generation of hypotheses from observations, population studies, large databases, new instruments, and serendipity; and the pathways of metabolic/molecular interaction.
January 26: Testing Hypotheses
The class will cover the process for testing hypotheses using a range of laboratory animals; a “day in the lab” virtual tour, including protocols, reagents, equipment, and instrumentation; hard proof versus statistics/chance for testing hypotheses to a specified degree of statistical significance; and intellectual property, patent, and publishing issues for generated results.
February 9: Clinical Trials — Human Testing
The third class will cover creating and coordinating teams of biologists, physicians, and volunteer patients; the three-phased FDA-guided approach to approval; patient enrollment, how to find a trial, and patient stories; and ethical issues for human experiments, history of abuse, and institutional review boards.
February 23: Transition to Standard of Care
The fourth class will address the challenges of overcoming resistance to change in the medical community; making medical practitioners aware of, and training them to use, new diagnostics and treatments; laboratory certification for new diagnostic tests and analyses; getting Medicare and insurance companies to approve payments; the formal test laboratory-certification process; and the cost effectiveness of new tests, treatments, and cures.
March 9: The Future of Medicine
The final class will address so-called “P4 medicine”: predictive, preventive, personalized, and participatory. Predictive medicine aims to determine one’s propensity to a disease based on genetic testing, proteomics, and metabolomics. Preventive medicine seeks to avoid the onset of a disease by encouraging patients to make lifestyle changes (adjusting diet, adding exercise, stopping smoking, reducing stress) and by using monitoring devices linked to doctors’ offices. Personalized medicine is designed to get the right treatment to the right patient at the right time. Participatory medicine educates patients so that they can be informed participants in their medical care.