If Sammy Jo Wilkinson had a spirit animal, it would be Marty McFly. For the past four years, the 51 year-old California resident has been using stem cell therapy to beat her secondary progressive multiple sclerosis back into remission. Gone is the paralysis to the left side of her face and the numbness in her fingers. In February, she walked for the first time in years. “I’m living in a future that everybody will have some day,” says Wilkinson, who co-founded the patient’s rights group Patients for Stem Cells. “We’re trying to tell everybody the solution is here now, we just need a logical way to bring this to patients sooner rather than later.”
According to Congress, that logical way is the 21st Century Cures Act, a labyrinthine bill that would make the most significant changes in decades to how medical treatments are tested and brought to market. Politicians are working overtime to pass it before the new year—it’s the number one priority for the lame duck session, passing the House on November 30 and advancing through the Senate last night. Final passage is expected to follow later this week.
In some ways, the legislation lives up to its name: It includes ambitious goals to advance biomedical science, and will inject $4.8 billion into a long-stagnating National Institute of Health budget. But attached to those promises is a roadmap for abandoning the gold standard of medicine in favor of an expedited “middle path” for drugs, medical devices, and regenerative therapies. Critics say it’s deregulation in sheep’s clothing—and worry that both science and patients are going to suffer.
Whether you applaud or decry the legislation, it’s almost certain to pass and be signed into law, if not by President Obama, then by the incoming administration. Which means regenerative medicine is headed for prime time. Welcome to the era of “inject and see.”
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