The Bio Report

New Safety Concerns Identified After FDA Approval of One in Three Drugs

Nearly one in three drugs has a postmarket safety event, according to a study published earlier this month in JAMA. The study looked at 222 novel therapies approved between 2001 and 2010. We spoke to Nicholas Downing, clinical fellow in the Department of Medicine at Brigham and Women's Hospital and lead author of the study, about the findings, the limits of clinical trials, and whether the U.S. Food and Drug Administration needs to do more to improve surveillance of drugs once they are approved.

Why Climate Change Is a Public Health Concern

Climate change is not often viewed as a public health threat, but it can have unexpected consequences on the spread of infectious diseases. As changing temperatures make new areas more hospitable to mosquitos, its can raise the risk of mosquito-borne diseases, such as dengue, chikungunya, and zika in areas not usual thought as prone to outbreaks of tropical disease. We spoke to Erin Mordecai, assistant professor of Biology at Stanford University and lead author of a recent study in PLoS Neglected Tropical Diseases that looks at how climate change may affect the spread of mosquito-borne disease. We spoke to Mordecai about the study, what it means for potential infectious disease outbreaks, and how public health officials and drugmakers in the developed world may need to think differently about neglected tropical diseases.

Reflections on the Progress and Promise of Personalzied Medicines

Ten years ago, a group of San Francisco State University alumni working at Genentech got together with the Michael Goldman, the university’s chairman of the biology department, to establish the school’s annual Personalized Medicine Conference. This year, the conference will revisit topics from its past ten years as well as exploring the future of personalized medicine ask speakers to reflect on how personalized medicine has changed their lives. We spoke to SF State’s Goldman and Dan Maher, one of the alumni who drove the creation of the conference, about the state of personalized medicine, the pace of advances, and what’s surprised them most about where we are today.

Curing Cancer with Math

The promise of precision medicine to provide more effective and safer cancer therapies that target the genetics driving each patient’s disease has been hindered by the lack of understanding of the specific genetic alterations underlying many cancers. Elana Fertig thinks math can solve that problem. Fertig, with a nod to the algorithm Netflix uses to help recommend movies users might like, is working to identify the genes that drive an individual’s cancer. Fertig, assistant professor of Oncology Biostatistics and Bioinformatics at Johns Hopkins Kimmel Cancer Center, discussed the proliferation of genetic data relating to cancer, how researchers may be able to capitalize on that, and how such an approach may also bring a new understanding of why patients suffer relapses and develop resistance to cancer therapies.

How Healthcare Consumer Find and Use Price Information

For anyone who has ever sought to find the price of healthcare services before obtaining them it will come as little surprise that information is not readily available. A recent study from Public Agenda, with support from the Robert Wood Johnson Foundation and the New York State Health Foundation, set out to find how Americans seek and use healthcare price information. We spoke to David Schleifer Director of Research for Public Agenda about what extent healthcare consumers seek price information, the implications of having a system with little price transparency, and what can be done to fix the problem.

Why Infectious Disease Represents a National Security Threat

As the Trump Administration calls for significant increases in military spending, it is also seeking steep cuts to the National Institutes of Health, the Centers for Disease Control and Prevention and programs used to address issues of global health. Michael Osterholm director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in a recent op-ed in The New York Times argues that issues such as vaccine development, the need to combat antibiotic resistance, and respond to new infectious disease outbreaks are fundamental issues of national security. We spoke to Osterholm about global trends fueling the threat of infectious disease, the dangers of proposed budget cuts, and why the administration needs to invest in new ways to respond to the threats we face.

Recent Mumps Outbreaks Raise Question If New Vaccine Is Needed

Recent mumps outbreaks are raising questions about strategies to combat the spread of the virus. One issue of concern is that the current vaccine is designed to protect against a different strain of the virus than the one that is sparking the outbreaks. Though the vaccine can help prevent some people from getting the disease or minimize its effects, the outbreaks have raised questions about whether a new vaccine is needed. We spoke to Stanley Plotkin, an expert on vaccines and a member of the editorial board of the journal Clinical and Vaccine Immunology, about what’s driving the outbreak, whether boosters can adequately address the problem, and why developing a new vaccine is not an easy solution to the problem.

Proposed Legislation Would Weaken Genetic Privacy Protections

The landmark legislation known as the Genetic Information Nondiscrimination Act of 2008, or GINA, anticipated growing concerns about genetic privacy, although it left much work undone. Now, though, as genetic information proliferates, proposed legislation would weaken protections by allowing employers to compel employees to share their genetic information in workplace wellness programs. Though voluntary, those who choose not to share this information could face thousands of dollars more for health insurance, according to reports. We spoke to Jeremy Gruber, past president of the Council for Responsible Genetics and someone credited with helping enact GINA, about the proposed legislation, what more needs to be done to protect genetic information, and how to best balance privacy concerns with the opportunities to leverage genetic data to better understand health and wellness.