Meet Jimmy Clark
Why not, I ask. Why not? Where are our priorities?
14. Annualized Cost to the Government
Data analysis by ATSDR may result in action taken by the Division of Toxicology and Human Health Studies in response to the required CDC mandate in maintaining preventive health activities and surveillance systems. The action taken will vary, depending on the analysis.
The total cost to the federal government for the collection of this information for the three year ongoing project is $3,300,000 as itemized below.
Annual ATSDR personnel costs $420,000
Additional expenses will be incurred by ATSDR in order to operate a successful surveillance program/registry. Four staff will contribute to this program: a Senior Scientist (25% contribution=$75,000), and a program analyst (100% contribution = $100,000) A contractor will be used to maintain the web portal for case registration and participation in surveys in addition to providing public user support 40 hours per week ($500,000). Lesser expenses may include computer resources, telephone calls, and recruitment materials (approximately $5,000).
The estimated annual cost to the government is $1,100,000.
Members of the ALS patient community are pleased to announce the creation of a new organization, Hope NOW for ALS, (www.HopenowforALS.org ) The mission of this grassroots organization, comprised of people with ALS (PALS) and their families and friends, is “to expedite access to promising investigational drugs for the current generation of PALS through the FDA’s Accelerated Approval Program (AAP) and other pathways, and to speed up ALS drug development by promoting improved alternative and humane designs for clinical trials.” Hope NOW for ALS is hosting the “ALS Rally for Faster Drug Approval” in Washington D.C. on May 11 and hundreds are expected to attend from across the country. www.meetup.com/ALS-Faster-
ALS, also known as Lou Gehrig’s Disease, is a fatal disease for which there is currently no cure and no effective treatment to stop the progression. The average life expectancy after diagnosis is two to five years. Some live longer but about half will pass away in under three years. The genesis for Hope NOW for ALS was a petition, www.change.org/ALSMedication, started in January calling for “accelerated approval” of a promising new ALS drug called GM604. Through the campaign, many in the patient community became aware of the outdated and broken drug approval system based on the 1962 “gold standard” or double blind randomized controlled trial (RCT) protocol required for new drugs to be approved. This 53-year-old protocol requires Phase I, II, III trials that take 10 to 15 years and require tens of millions of dollars. Many promising drugs never make it to Phase III due to the prohibitive cost, or because they don’t meet stringent FDA criteria (P=.05) that often dismisses data even when they demonstrate a drug is effective on a subset of the population. The current generation of people with ALS has almost no hope for survival unless treatments become available much faster through the Accelerated Approval Program (AAP) adopted in 1992 as a result of AIDS-HIV activism. AAP was designed to speed up drug approvals for serious conditions that have an unmet medical need. Still, not a single drug for ALS has moved through the AAP process. Hope NOW for ALS intends to change that.
Nick Grillo, Jehad Majed, Eric Valor, and Linda ClarkEmail: info@HopenowforALS.org