Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try.

Background: For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards. Methods: This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes. Results: Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients. Conclusion: Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine.

A matter of life and longer life.

While the major scientific discoveries that would extend the length and health of human lives are not yet here, the research that could create them is already underway. As prospects for a world in which extended and improved lives inches closer into reality, the discourse about what to consider as we move forward grows richer, with corporate executives, ideologues, scientists, theologians, ethicists, investigative journalists, and philosophers taking part in imagining and anticipating the rich array of humanity's possible futures. Drawing from in-depth interviews with key stakeholders (n = 22), we offer empirical insights into key values and beliefs animating the "longevity movement," including what constitutes an ideal human state, the imperative to intervene, and the role of individual liberty and concerns for equality. Emerging from these interviews are common concerns about reducing suffering, preserving diversity in visions of successful aging and how best to promote access to a future that may not remain hypothetical for long.

Erratum: Revisiting the Warnock rule.

This corrects the article DOI: 10.1038/nbt.4015.

Stem cell patents after the america invents act.

Under the newly passed Leahy-Smith America Invents Act (AIA), the U.S. Patent and Trademark Office may hear new challenges to stem cell patents. Here, we explore how the new law affects challenges to stem cell patents, focusing on two recent cases, and discuss the future of stem cell patent disputes.

Money and morals: ending clinical trials for financial reasons.

Too often, biopharmaceutical companies stop their clinical trials solely for financial reasons. In this chapter, we discuss this phenomenon against the backdrop of a 2011 decision by Geron Corporation to abandon its stem cell clinical trial for spinal cord injury (SCI), the preliminary results of which were released in May 2014. We argue that the resultant harms are widespread and are different in nature from the consequences of stopping trials for scientific or medical reasons. We examine the ethical and social effects that arise from such decisions and discuss them in light of ethical frameworks, including duties of individual stakeholders and corporate sponsors. We offer ways that sponsors and clinical sites can ensure that trials are responsibly started, and once started adequately protect the interests of participants. We conclude with recommendations that industry sponsors of clinical trials should adopt in order to advance a collective and patient-centered research ethic.

The case for stem cell counselors.

In this article, Scott describes how a new counseling profession could support clinical sites and patients enrolling in stem cell clinical trials. A possible model is proposed, along with a curriculum that would provide counselors with the tools to address challenges facing the clinical stem cell field. Finally, a candidate recruitment and clinical site interface scheme is offered.