The History of Hope NOW for ALS
What began with a petition on Change.Org (petition now closed) quickly evolved into a series of petitions that generated over half a million signatures worldwide. The catalyst for what is now a global grassroots patient-led movement was a drug called GM604. In October 2014 a press release from the drug maker, Genervon, reported promising results of a Phase II clinical trial and the ALS patient community took notice. We started with petitions calling on the FDA to grant accelerated approval to GM604 and quickly followed that with the creation of social media pages and a rally in Washington DC, on March 25, 2015. Through these efforts we have learned we need to do MUCH MORE to expedite drug development and approvals for ALS and formed the new organization, Hope NOW for ALS.
Hope Now For ALS (HNFA) is a group of People with ALS (PALS) who are devoted entirely to finding ways to develop and use 21st Century technology to cure a 19th Century disease. Currently, the regulatory authorities in the United States of America are mired in 1962-era 20th Century rules and thinking when it comes to treatment options for ALS. This spills over into the pharmaceutical industry and stifles progress. Consequently, people with ALS die waiting for experimental treatments to slowly crawl through the approval process and some promising drugs are simply shelved because companies run out of money trying to finance multiple long and expensive clinical trials.
HNFA seeks out and helps develop 21st Century ways to conduct clinical trials that are shorter in time, require fewer participants, are more humane in design, but produce the same rigorous scientific results. The FDA rules for double-blind placebo-controlled clinical trials were the pinnacle of scientific rigor when they were first implemented. But medical understanding and technology has greatly evolved since the middle of the 20th Century. HNFA works with industry to develop and use these new techniques and technologies, then to adopt them into their proposed clinical trial plans. We also work with government regulatory authorities to recognize the new techniques and technologies as scientifically valid and to accept the results provided by the new 21st Century clinical trial designs. Additionally, we push the regulatory authorities to use the flexibility granted them by law to more quickly make experimental treatment options available to patients.