This paper should be required reading for any biopharma exec, regulator or advocate/advocacy group. The focus right now is on one brave woman, @Chance4Lisa, and one company, @biogen, but the core issue is larger and fundamental to who we are. /1 https://twitter.com/gregggonsalves/status/1381306495850123270

We have been, since the 1990s, a country that gives patients facing a terminal illness and unable to be part of a potentially life changing clinical trial the chance to access that therapy rather than condemning them to death. As this paper lays out: /2

“Parallel track and early release of ddI have also resulted in an unusual confluence of interests among AIDS activists, regulators, drug companies, and some key scientific researchers. Government officials saw early release as a means of showing compassion and responsiveness.../3

... at a time when existing research and regulatory structures seemed rigid and uncaring. Drug companies and top government regulators saw early access as another step toward the reduced regulation of the pharmaceutical industry.../4

...Finally, activists saw parallel track as providing greater autonomy in decision making for persons with HIV infection.”

History is now repeating itself in the neuro and rare disease fights. Back then HIV advocates were the front line. Now it is ALS advocates./5

We cannot turn a blind eye to the efforts to reverse humane, critical protections in our health care system. Join us in standing for what is good and right. @gregggonsalves @AdyBarkan @morethanmySLE @tmprowell

This is the time to act. /end