The NIH's Collins Presents Declaration Outlining Impact of hESC Research Ban

Abstract

In the wake of a district judge's decision on August 23, 2010, to block the use of federal funds for human embryonic stem cell research (hESC), the Obama administration on August 31, 2010, formally challenged the court order and filed notice of plans to appeal the decision to the U.S. Court of Appeals. “The government is seeking a stay of the court's injunction to prevent the irreparable harm and financial harm that could occur if these lifesaving research projects are forced to abruptly shut down,” Justice Department spokesperson Tracy Schmaler said in a statement. “The great potential for significant additional medical breakthroughs is at risk if this research is halted pending the appeals process.” The director of the National Institutes of Health (NIH), Dr. Francis Collins, delivered a separate 12-page declaration to the federal court about the importance of hESC research and the harm that will come from Judge Royce Lamberth's stem cell decision. He pointed out that since the first awards in 2002, the NIH has a total aggregated investment of $546 million in intramural and extramural hESC research. “As a result of these investments, NIH funded animal studies, often referred to as preclinical studies, are underway to test whether these cells or tissues derived from embryonic stem cells, human and/or mouse, are of benefit for retinal degeneration, stroke, liver failure, muscular dystrophy, myelin deficiencies, motor neuron disease and Huntington's disease.” Collins added that the first clinical trial of hESC-derived therapy has received US Food and Drug Administration (FDA) approval to begin enrolling spinal cord injury patients. “This is a remarkable achievement and heralds what should be the beginning of a new era in cell-based therapy. “Equally important, differentiated cells derived from hESC are already successfully being used to develop new therapeutic drugs for a number of diseases including amyotrophic lateral sclerosis (‘Lou Gehrig’s disease') and spinal muscular atrophy, to name just a few. Without dependable and consistent support from NIH, hESC research and development will be dealt a critical blow that will have dire ramifications for those suffering from many diseases and disorders [that] may be treatable with hESC-based therapies or drugs developed using hESC testing.” The declaration also considers the impact of the court's order on the disruption to intramural and extramural research and disruption to the agency's administration and mission. See: http://www.scribd.com/doc/36697386/Final-Collins-Declaration-Aug-31-2010.