BioCentury is providing in-depth analysis of the sudden impact of social media on difficult medical and ethical decisions surrounding compassionate access to experimental medicines. See the story from a multitude of angles in our continuing coverage.

Commentary: Josh Hardy: An unanswered call
BioCentury proposed a framework for compassionate access in March 2014. A year after the Josh Hardy crisis, it's still the best idea on the table.

Viral crossroads
by Steve Usdin, Washington Editor
The Josh Hardy case highlights the inadequacy of the process for deciding when to grant access to experimental medicines outside of clinical trials. It also may be a catalyst for change.

Josh Hardy chronicles
by Steve Usdin, Washington Editor
While social media users may be claiming the credit, in the end Chimerix and FDA had to clear a way to provide brincidofovir to a handful of patients while opening a door for broader access via a bigger trial.

Commentary: The equitable pathway
It is possible to identify basic principles that should underlie a transparent system for reviewing compassionate use requests, no matter who does the assessment.

Figure: Decision-Tree for Compassionate Use

Reasons unknown
by Susan Schaeffer, Editor
Whatever caused Kenneth Moch to depart Chimerix as president and CEO, it wasn't stock performance.

ASCO's honest broker
by Steve Usdin, Washington Editor
ASCO is developing an initiative to facilitate off-label access to targeted cancer therapies. If successful, the system could serve as a model for third-party bodies that could manage early access to experimental therapies.

States' rights
by Steve Usdin, Washington Editor
State right-to-try laws reflect deep dissatisfaction with the pace of drug development, but industry and some patient advocates don’t think they’ll work.

BioCentury TV: Compassionate Access - #conundrum, April 13

Segment 1: The Twitter Campaign
Aimee Hardy, mother of cancer-patient Josh Hardy, discusses her family's successful social media campaign to obtain the experimental drug brincidofovir.

Segment 2: Stakeholder Alignment
Kids v. Cancer's Nancy Goodman, FDA's Richard Klein and Brookings' Darshak Sanghavi consider social media's use to gain access to compassionate-use drugs: is it a systemic weakness or a way to balance competing needs? 

Segment 3: FDA Facilitation
Guests debate FDA's role mediating compassionate-use requests from desperate patients and the moral, operational burden to pharmaceutical companies.

Segment 4: Who Will Pay?
Goodman and Sanghavi comment on who will fund access to experimental drugs; expanding clinical trials is considered.

Patching compassionate access
by Steve Usdin, Washington Editor
Congress is gearing up to reconsider compassionate access to drugs, but wholesale reform looks unlikely.

Targeting PREA
by Steve Usdin, Washington Editor
Oncologists and patient advocates want Pediatric Research Equity Act mandates to study new targeted cancer drugs in children.

BioCentury TV: Kids, Cancer & Congress, Sept. 28

BioCentury TV