The Bio Report

President Jimmy Carter, at a recent press conference discussing his cancer diagnosis and treatment, expressed his wish to outlive the last Guinea worm. The Carter Center, since 1986, has led a global effort to eradicate Guinea worm disease with great success and its goal is within reach. We spoke to Ernesto Ruiz-Tiben, director of The Carter Center’s Guinea Worm Eradication Program, about its efforts, the history behind it, and what lessons can be drawn in combating other public health threats throughout the world.

Sprout Pharmaceuticals earlier this week won a controversial U.S. Food and Drug Administration approval of Addyi, the first drug approved in the United States to treat female sexual dysfunction. Following the news, Valeant Pharmaceuticals said it would acquire Sprout for $1 billion. We spoke filmmaker Liz Canner, director of the documentary Orgasm, Inc., about Addyi, the drug industry’s long standing pursuit of a female Viagra, and why its approval is troubling to many people.

Earlier this month in a preemptive challenge from Amarin Pharma against the U.S. Food and Drug Administration a federal judge ruled that the FDA cannot prohibit a drugmaker from promoting the off-label use of a drug if it does so through the dissemination of truthful and non-misleading information. The decision about the First Amendment Rights of a pharmaceutical company is seen as a significant ruling in a long-standing battle between the agency and the industry that has played out over the past 20 years. We spoke to John Kamp, executive director of the Coalition for Healthcare Communication, about the case, the issues behind it, and its implications for how the industry and agency will act going forward.

Drugmakers about 10 percent of the time fail to report serious adverse events to the U.S. Food and Drug Administration within the time required, according to a recent study in the Journal of the American Medical Association. We spoke to Pinar Karaca-Mandic, study co-author and associate professor of Health Policy and Management at the School of Public Health at the University of Minnesota, about the study, the concerns it raises, and whether regulators need to rethink the way adverse events are reported.

A growing problem with drug resistant infections acquired in hospitals is catching the eye of Consumer Reports, which has added the incidence of two common and deadly infections to their hospital ratings. The ratings come in the second part of a three-part investigation in the antibiotic crisis. We spoke to Doris Peter, director of Consumer Reports’ Health Ratings Center, about the study, what the highest rated hospitals are doing that the lower rated ones are not, and things patients can do to safeguard themselves when they face a hospital stay.

The controversy over the high price of new drugs and the question of the value they provide will come under increased scrutiny thanks to a grant to a Boston-based nonprofit that works to get at these questions. The Laura and John Arnold Foundation this week announced it is providing $5.2 million to the Institute for Clinical and Economic Review aimed at transforming the way new drugs are evaluated and priced. We spoke to Sarah Emond, COO of the institute, about the work it does, what this new grant will do to expand that work, and how to get a the question of the value of new drugs.

Researchers at the University of California, Berkeley and the Gladstone Institutes have grown beating cardiac tissue from stem cells in work that may lead to new ways to quickly screen for drugs likely to cause birth defects in the heart and identify drugs that may be dangerous during pregnancy. We spoke to Bruce Conklin, a senior investigator at the Gladstone Institute of Cardiovascular Disease, about the work, which was published in the journal Nature Communications, the promise it has for providing more accurate insights than animal models, and whether the approach could be expanded to other cell types to screen for drug toxicity to other organs.

For many patients with rare and difficult to diagnose conditions, it can take many years and many doctors to find a correct answer. CrowdMed is trying to offering an alternative to patients by allowing them to tap the wisdom of crowds and letting medical detectives who sign on to the site try to find the right answer. We spoke to Jared Heyman, founder and CEO of CrowdMed, about the problem with the traditional way doctors diagnose patients, the wisdom of crowds, and the case for making medicine a team sport.

Last year, the biotechnology industry set records across the board for financial metrics, a reflection of product success, new drug approvals, and free-flowing investment capital. Despite the record performance, concerns continue about growing pricing pressure and maturing pipelines that represent challenges with which the industry must contend. We spoke to Glen Giovannetti, EY’s Global Life Sciences Leader about his firms recently released Beyond Borders report, what the numbers tell us, and what the industry will need to do to keep the good times rolling.

A detailed view of funding of emerging therapeutic companies over the past ten years shows despite a rebound in venture financing, companies continue to struggle to find early-stage money. Nevertheless, the report shows the overall health of investment in the sector is thriving. We spoke to Dave Thomas, senior director of industry research and analysis for the Biotechnology Industry Organization and co-author of the report, about BIO’s findings, what therapeutic areas attracted the most financing, and what impact the capital markets have had on partnering and licensing activity.